Orthodontic AppliancesPhase 3NCT07210697
Orthodontic Pain Alleviation With Chewing Gum
A Phase 3 study testing Xylitol Gum in people with Orthodontic Appliances, run by West Virginia University at 1 site in United States.
Trial summary
The aim of this study is to determine whether chewing gum can alleviate orthodontic treatment discomfort and improve orthodontic treatment experience. The long-term goal is to enable clinicians to decide whether prescription of chewing gum at the placement of orthodontic appliances can improve patient experience with… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Orthodontic Appliances
- What is being tested?
- Xylitol Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant and Parents able to sign and understand consent
- Ability to chew gum
Who cannot join
- Pregnant or Breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
Peter, DMD, 304-293-3223
Karissa Spokane, 724-630-5624, kls0006@mix.wvu.edu
About this study
The aim of this study is to determine whether chewing gum can alleviate orthodontic treatment discomfort and improve orthodontic treatment experience. The long-term goal is to enable clinicians to decide whether prescription of chewing gum at the placement of orthodontic appliances can improve patient experience with orthodontic treatment. In specific, a total of 60 patients under the age of 18 will be recruited for the study. Consent will be signed by both the child patient and the parents. 30 patients will be asked to chew xylitol gum and the other 30 patients will refrain from chewing gum and serve as the control group. At the appointment for insertion of orthodontic appliances, patients will be instructed to chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day. Patients will participate in a survey at the following timepoints- 4 hours, 24 hours, 48 hours and 7 days. The expectation is that this study will determine the effectiveness of using xylitol to decrease pain in orthodontic patients.
- Conditions
- Orthodontic Appliances
- Being tested
- Xylitol Gum
- Keywords
- Orthodontic Pain, xylitol gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol GumDrug
1 gram of xylitol per piece of gum with one serving being 2 pieces of gum
| Study group | Role | What they receive |
|---|---|---|
| Xylitol Gum | Active comparator | Chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day. Receives: Drug: Xylitol Gum |
| No Gum | No intervention | Control group that will refrain from chewing gum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale Baseline
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Measured: Baseline
Visual analogue scale 4 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Measured: 4 hours post treatment
Visual analogue scale 24 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Measured: 24 hours post treatment
Visual analogue scale 48 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Measured: 48 hours post treatment
Visual analogue scale 1 week post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Measured: 1 week post treatment
Comfort Level for Biting Baseline
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for Biting 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for Biting 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for Biting 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for Biting 1 week post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Comfort Level for Chewing Baseline
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for Chewing 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for Chewing 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for Chewing 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for Chewing 1 week post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Comfort Level for Fitting Back Teeth Baseline
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for Fitting Back Teeth 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for Fitting Back Teeth 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for Fitting Back Teeth 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for Fitting Back Teeth 1 week post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Comfort Level for Fitting Front Teeth Baseline
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for Fitting Front Teeth 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for Fitting Front Teeth 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for Fitting Front Teeth 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for Fitting Front Teeth 1 week post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Comfort Level for Speech Baseline
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for Speech 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for Speech 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for Speech 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for Speech 1 week post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Comfort Level for popping and clicking of the jaw joint Baseline
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Comfort Level for popping and clicking of the jaw joint 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Comfort Level for popping and clicking of the jaw joint 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Comfort Level for popping and clicking of the jaw joint 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Comfort Level for popping and clicking of the jaw joint 1 week post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with appearance of teeth Baseline
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with appearance of teeth 4 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with appearance of teeth 24 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with appearance of teeth 48 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with appearance of teeth 1 week post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with appearance of facial profile Baseline
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with appearance of facial profile 4 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with appearance of facial profile 24 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with appearance of facial profile 48 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with appearance of facial profile 1 week post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with general appearance of face Baseline
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with general appearance of face 4 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with general appearance of face 24 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with general appearance of face 48 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with general appearance of face 1 week post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with overall appearance Baseline
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with overall appearance 4 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with overall appearance 24 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with overall appearance 48 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with overall appearance 1 week post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with general health Baseline
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with general health 4 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with general health 24 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with general health 48 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with general health 1 week post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with self-esteem Baseline
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with self-esteem 4 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with self-esteem 24 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with self-esteem 48 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with self-esteem 1 week post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with socializing Baseline
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with socializing 4 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with socializing 24 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with socializing 48 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with socializing 1 week post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with school performance Baseline
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with school performance 4 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with school performance 24 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with school performance 48 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with school performance 1 week post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Satisfaction with being out in public Baseline
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: Baseline
Satisfaction with being out in public 4 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 4 hours post treatment
Satisfaction with being out in public 24 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 24 hours post treatment
Satisfaction with being out in public 48 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 48 hours post treatment
Satisfaction with being out in public 1 week post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Measured: 1 week post treatment
Self-Reported Level of Neuroticism Baseline
Measured using the question "How do you fall on a scale of neuroticism?" Investigators provide the definition of neuroticism as the following: Neuroticism is a tendency to experience emotions such as anxiety, depression, and anger. The scale used is a Likert type scale with 0= Very Neurotic, 5= Somewhat Neurotic, and 10= Not Neurotic. Higher scores indicate lower levels of neuroticism.
Measured: Baseline
Self-Reported Introversion/extroversion Baseline
Measured using the question "How do you fall on a scale of introversion/extroversion?" Investigators provide the definition of neuroticism as the following: Introvert is someone who is socially reserved; Ambivert falls in the middle; Extrovert is someone who is very socially outgoing. The scale used is a Likert type scale with 0= Introvert, 5= Ambivert, and 10= Extrovert. Higher scores indicate higher levels of being socially outgoing.
Measured: Baseline
Adherence to chewing gum instructions 4 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Measured: 4 hours post treatment
Adherence to chewing gum instructions 24 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Measured: 24 hours post treatment
Adherence to chewing gum instructions 48 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Measured: 48 hours post treatment
Adherence to chewing gum instructions 1 week post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Measured: 1 week post treatment
Adherence to avoiding pain medications instructions 4 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Measured: 4 hours post treatment
Adherence to avoiding pain medications instructions 24 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Measured: 24 hours post treatment
Adherence to avoiding pain medications instructions 48 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Measured: 48 hours post treatment
Adherence to avoiding pain medications instructions 1 week post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Measured: 1 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AppliancesStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Ngan, West Virginia University
- Investigators
- Peter Ngan, DMD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210697
- Sponsor's protocol ID
- 2506181765
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Pain Alleviation With Chewing Gum
- ClinicalTrials.gov ID
- NCT07210697
- Acronym / sponsor ID
- 2506181765
- Conditions
- Orthodontic Appliances
- Keywords
- Orthodontic Pain, xylitol gum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether chewing gum can alleviate orthodontic treatment discomfort and improve orthodontic treatment experience. The long-term goal is to enable clinicians to decide whether prescription of chewing gum at the placement of orthodontic appliances can improve patient experience with orthodontic treatment. In specific, a total of 60 patients under the age of 18 will be recruited for the study. Consent will be signed by both the child patient and the parents. 30 patients will be asked to chew xylitol gum and the other 30 patients will refrain from chewing gum and serve as the control group. At the appointment for insertion of orthodontic appliances, patients will be instructed to chew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day. Patients will participate in a survey at the following timepoints- 4 hours, 24 hours, 48 hours and 7 days. The expectation is that this study will determine the effectiveness of using xylitol to decrease pain in orthodontic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylitol Gum | Active comparator | Drug: Xylitol GumChew one serving or two pieces of xylitol gum three times per day for a total of six grams of xylitol per day. |
| No Gum | No intervention | –Control group that will refrain from chewing gum. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participant and Parents able to sign and understand consent
- Ability to chew gum
Key exclusion criteria (1 listed)
- Pregnant or Breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol Gum1 gram of xylitol per piece of gum with one serving being 2 pieces of gum | Drug | Xylitol Gum |
Primary outcome
Visual analogue scale Baseline
Time frame: Baseline
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Visual analogue scale 4 hours post treatment
Time frame: 4 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Visual analogue scale 24 hours post treatment
Time frame: 24 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Visual analogue scale 48 hours post treatment
Time frame: 48 hours post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Visual analogue scale 1 week post treatment
Time frame: 1 week post treatment
Assessment of pain on a visual analogue scale with the scale being 0= very comfortable and 10= severe discomfort with 10 being the worst outcome.
Comfort Level for Biting Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Biting 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Biting 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Biting 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Biting 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning biting." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Chewing Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Chewing 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Chewing 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Chewing 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Chewing 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning chewing." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Back Teeth Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Back Teeth 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Back Teeth 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Back Teeth 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Back Teeth 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning fitting your back teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Front Teeth Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Front Teeth 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Front Teeth 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Front Teeth 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Fitting Front Teeth 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning fitting your front teeth together." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Speech Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Speech 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Speech 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Speech 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for Speech 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning speech." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for popping and clicking of the jaw joint Baseline
Time frame: Baseline
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for popping and clicking of the jaw joint 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for popping and clicking of the jaw joint 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for popping and clicking of the jaw joint 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Comfort Level for popping and clicking of the jaw joint 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select the level of comfort you have concerning popping and clicking of the jaw joint." using a Likert type scale of 0-10 [very comfortable (0) to mild discomfort (5) to severely uncomfortable (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of teeth Baseline
Time frame: Baseline
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of teeth 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of teeth 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of teeth 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of teeth 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about the appearance of your teeth" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of facial profile Baseline
Time frame: Baseline
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of facial profile 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of facial profile 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of facial profile 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with appearance of facial profile 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about your facial profile" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general appearance of face Baseline
Time frame: Baseline
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general appearance of face 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general appearance of face 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general appearance of face 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general appearance of face 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about the general appearance of your face" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with overall appearance Baseline
Time frame: Baseline
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with overall appearance 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with overall appearance 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with overall appearance 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with overall appearance 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about your overall appearance" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general health Baseline
Time frame: Baseline
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general health 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general health 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general health 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with general health 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about your general health" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with self-esteem Baseline
Time frame: Baseline
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with self-esteem 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with self-esteem 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with self-esteem 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with self-esteem 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about your self-esteem" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with socializing Baseline
Time frame: Baseline
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with socializing 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with socializing 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with socializing 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with socializing 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how comfortable you feel about socializing with peers" using a Likert type scale of 0-10 [confident in socializing (0) to neutral (5) to avoid socializing (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with school performance Baseline
Time frame: Baseline
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with school performance 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with school performance 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with school performance 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with school performance 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about your performance in school" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with being out in public Baseline
Time frame: Baseline
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with being out in public 4 hours post treatment
Time frame: 4 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with being out in public 24 hours post treatment
Time frame: 24 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with being out in public 48 hours post treatment
Time frame: 48 hours post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Satisfaction with being out in public 1 week post treatment
Time frame: 1 week post treatment
Measured using the question "Select how you feel about being out in public" using a Likert type scale of 0-10 [very good (0) to neutral (5) to very bad (10)] with 0 being the best outcome and 10 being the worst.
Self-Reported Level of Neuroticism Baseline
Time frame: Baseline
Measured using the question "How do you fall on a scale of neuroticism?" Investigators provide the definition of neuroticism as the following: Neuroticism is a tendency to experience emotions such as anxiety, depression, and anger. The scale used is a Likert type scale with 0= Very Neurotic, 5= Somewhat Neurotic, and 10= Not Neurotic. Higher scores indicate lower levels of neuroticism.
Self-Reported Introversion/extroversion Baseline
Time frame: Baseline
Measured using the question "How do you fall on a scale of introversion/extroversion?" Investigators provide the definition of neuroticism as the following: Introvert is someone who is socially reserved; Ambivert falls in the middle; Extrovert is someone who is very socially outgoing. The scale used is a Likert type scale with 0= Introvert, 5= Ambivert, and 10= Extrovert. Higher scores indicate higher levels of being socially outgoing.
Adherence to chewing gum instructions 4 hours post treatment
Time frame: 4 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Adherence to chewing gum instructions 24 hours post treatment
Time frame: 24 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Adherence to chewing gum instructions 48 hours post treatment
Time frame: 48 hours post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Adherence to chewing gum instructions 1 week post treatment
Time frame: 1 week post treatment
Percentage of participants that adhered to the instructions of not chewing gum. Measured using the yes/no question "Did you follow the instructions about chewing gum?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the chewing gum instructions.
Adherence to avoiding pain medications instructions 4 hours post treatment
Time frame: 4 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Adherence to avoiding pain medications instructions 24 hours post treatment
Time frame: 24 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Adherence to avoiding pain medications instructions 48 hours post treatment
Time frame: 48 hours post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Adherence to avoiding pain medications instructions 1 week post treatment
Time frame: 1 week post treatment
Percentage of participants that adhered to the instructions of avoiding pain medication. Measured using the yes/no question "Did you follow the instructions about avoiding pain medications such as Tylenol or Advil?" Responses are binary: Yes or No. A response of "Yes" indicates adherence to the avoiding pain medications instructions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Ngan, DMD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xylitol Gum in people with Orthodontic Appliances, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Ngan, DMD (304-293-3223, pngan@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale Baseline (time frame: Baseline). The study lists 90 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.