Orthodontic PainNCT04836234
Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement
A study testing Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum in people with Orthodontic Pain, run by University of Malaya at 1 site in Malaysia.
Trial summary
Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteMalaysia
- Study dates
- 6 Mar 2019to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances
- Orthodontic treatment include the extraction of the permanent first or second premolars
- Age 16 years and above
Who cannot join
- Significant medical problem or cleft lip and palate.
- Pregnant lady
- Occurrence of using analgesics or antibiotics
- History of asthma or unstable asthma the last year
- Oral surgery in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya
Kuala Lumpur, Kuala Lumpur, 50603
Pei San Poon, 0127691145, peisanpss@gmail.com
About this study
Official title: The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain. However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement. This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.
Read the detailed description
Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage.
The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment.
This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.
- Conditions
- Orthodontic Pain
- Being tested
- Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum
- Keywords
- Chewing gum, Orthodontic pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrigley Extra Strawberry Flavour Sugar Free Chewing GumOther
Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum. They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required. Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain. They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used. Receives: Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum |
| Control group | No intervention | Participants will not receive any prescription after the separators and initial arch wires placement. They will be specifically asked not to chew chewing gum. As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Measured: At 6 hours after separators and initial arch wire placement.
Pain assessment after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Measured: At 24 hours after separators and initial arch wire placement.
Pain assessment after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Measured: At 48 hours after separators and initial arch wire placement.
Secondary outcomes (4)
Reported use of chewing gum and analgesics.
Amount of chewing gums and medications consumed after the separator and initial arch wire placement
Measured: Immediately after the separator and archwire placements until up to 6 hours
Reported use of chewing gum and analgesics.
Amount of chewing gums and medications consumed after the separator and initial arch wire placement
Measured: from 6 hours to 24 hours after the separator and archwire placements
Reported use of chewing gum and analgesics.
Amount of chewing gums and medications consumed after the separator and initial arch wire placement
Measured: from 24 hours to 48 hours after the separator and archwire placements
Recorded appliances breakages.
Frequency of appliances breakages
Measured: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start6 Mar 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Method of randomization using online randomization software. All 108 participants will be randomly allocated into 2 groups with a 1:1 allocation. Participants will be grouped into either group 1 (Intervention group, chewing gum) or group 2 (Control group, no chewing gum given) by using block randomization with block size of 4. Each group will have 54 participants. Concealment of the allocation sequence will be done by concealing the sequence in opaque envelopes.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siti Adibah Othman, Prof, Study director, Faculty of Dentistry, University of MalayaZamros Yuzadi Mohd Yusof, Prof, Study director, Faculty Of Dentistry, University of MalayaPoon Pei San, Principal investigator, Faculty of dentistry, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836234
- Sponsor's protocol ID
- DGD170001
- Status last verified
- Apr 2021
- First submitted
- 5 Nov 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22.
PubMed 22812440Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018.
PubMed 27476354Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
PubMed 8893104Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1.
PubMed 20578865Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020.
PubMed 19361739
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04836234
- Acronym / sponsor ID
- DGD170001
- Conditions
- Orthodontic Pain
- Keywords
- Chewing gum, Orthodontic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain. However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement. This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.
Detailed description
Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage.
The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment.
This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Method of randomization using online randomization software. All 108 participants will be randomly allocated into 2 groups with a 1:1 allocation. Participants will be grouped into either group 1 (Intervention group, chewing gum) or group 2 (Control group, no chewing gum given) by using block randomization with block size of 4. Each group will have 54 participants. Concealment of the allocation sequence will be done by concealing the sequence in opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Wrigley Extra Strawberry Flavour Sugar Free Chewing GumParticipants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum. They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required. Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain. They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used. |
| Control group | No intervention | –Participants will not receive any prescription after the separators and initial arch wires placement. They will be specifically asked not to chew chewing gum. As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances
- Orthodontic treatment include the extraction of the permanent first or second premolars
- Age 16 years and above
Key exclusion criteria (5 listed)
- Significant medical problem or cleft lip and palate.
- Pregnant lady
- Occurrence of using analgesics or antibiotics
- History of asthma or unstable asthma the last year
- Oral surgery in the previous 4 weeks
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 |
|---|---|---|
| Wrigley Extra Strawberry Flavour Sugar Free Chewing GumWrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces | Other | intervention group |
Primary outcome
Pain assessment after separators and initial arch wire placement.
Time frame: At 6 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Pain assessment after separators and initial arch wire placement.
Time frame: At 24 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Pain assessment after separators and initial arch wire placement.
Time frame: At 48 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
4 secondary outcomes
Reported use of chewing gum and analgesics.
Time frame: Immediately after the separator and archwire placements until up to 6 hours
Reported use of chewing gum and analgesics.
Time frame: from 6 hours to 24 hours after the separator and archwire placements
Reported use of chewing gum and analgesics.
Time frame: from 24 hours to 48 hours after the separator and archwire placements
Recorded appliances breakages.
Time frame: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 22812440Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22.
- Background: PubMed 27476354Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018.
- Background: PubMed 8893104Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
- Background: PubMed 20578865Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1.
- Background: PubMed 19361739Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020.
- 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. This study is not recruiting at the moment.
Siti Adibah Othman, Prof study director
Faculty of Dentistry, University of Malaya
Zamros Yuzadi Mohd Yusof, Prof study director
Faculty Of Dentistry, University of Malaya
Poon Pei San principal investigator
Faculty of dentistry, University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum in people with Orthodontic Pain, run by University of Malaya at 1 site in Malaysia.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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 Malaysia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Poon Pei San (0127691145, peisanpss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment after separators and initial arch wire placement. (time frame: At 6 hours after separators and initial arch wire placement.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836234, which also lists 5 linked publications.
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 8 Apr 2021.