XerostomiaNCT04289051
Clinical Evaluation of Oral Rinse for Xerostomia
A study testing HYDRAL Oral Rinse and BIOTENE® Oral Rinse in people with Xerostomia, run by Sunstar Americas at 1 site in United States.
Trial summary
Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- HYDRAL Oral Rinse and BIOTENE® Oral Rinse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 4 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have read, understood and signed an informed consent prior to being entered into the study.
- Must be 18 to 80 years of age, male or female.
- Have at least 20 natural or restored teeth.
- Have an unstimulated salivary flow rate <0.20 ml/minute which represents a significant reduction of normal salivary function
- Must have subjective xerostomia symptom: minimum level of 4 on a 10 centimeters Visual Analog Scale (VAS) [How would you score dryness of your mouth?]
- Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study.
- Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- Agree to comply with the conditions and schedule of the study.
Who cannot join
- Physical limitations or restrictions that might preclude normal tooth brushing.
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Presence of severe gingivitis with 30 or more sites showing bleeding on probing.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
- Chronic disease with concomitant oral manifestations other than xerostomia
- Conditions requiring antibiotic treatment prior to dental prophylaxis and invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants.
Show all 19Show fewer
- History of hepatic or renal disease, uncontrolled diabetes, or other serious conditions or transmittable diseases.
- Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
- Currently using bleaching trays
- History of radiotherapy, head and neck cancer or Sjogren's syndrome.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.
- Currently breast feeding
- Eating disorders
- Recent history of substance abuse
- Participation in other clinical studies within 14 days of screening
- Smoking >10 cigarettes/day
- Chewing tobacco
- Daily use of symptom alleviating products against xerostomia within 7 days of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, The Center for Dental Studies
Buffalo, New York, 14214
About this study
Official title: Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia
Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.
This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.
- Conditions
- Xerostomia
- Being tested
- HYDRAL Oral Rinse, BIOTENE® Oral Rinse, Placebo Oral Rinse
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYDRAL Oral RinseDevice
Application 4 times a day for two weeks
BIOTENE® Oral RinseDevice
Application 4 times a day for two weeks
Placebo Oral RinseDevice
Application 4 times a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| HYDRAL Oral Rinse | Experimental | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. Receives: Device: HYDRAL Oral Rinse; Device: BIOTENE® Oral Rinse; Device: Placebo Oral Rinse |
| BIOTENE® Oral Rinse | Active comparator | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. Receives: Device: HYDRAL Oral Rinse; Device: BIOTENE® Oral Rinse; Device: Placebo Oral Rinse |
| Placebo Oral Rinse | Placebo comparator | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. Receives: Device: HYDRAL Oral Rinse; Device: BIOTENE® Oral Rinse; Device: Placebo Oral Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline
100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome.
Measured: Baseline, 14 days
Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline
Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15).
Measured: Baseline, 14 days
Secondary outcomes (2)
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline
Assessment of oral functions by a dental professional. Eight categories were included in the assessment guide: voice, lips, mucous membranes, tongue, gums, teeth, saliva, and swallowing. Each category was described and rated from healthy (score 1) to severe (score 3). Scores for the categories were summed to calculate a total score per each subject (minimum total score: 8, maximum total score: 24). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -16, maximum change: 16).
Measured: Baseline, 14 days
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline
Unstimulated whole saliva was collected over a 5-minute time period and the volume was measured. Change in mL per minute was calculated by subtracting the measurement at baseline from the measurement at 14 days.
Measured: Baseline, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start19 Aug 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289051
- Sponsor's protocol ID
- CLP-2020-02-01-1
- Status last verified
- Dec 2021
- First submitted
- 26 Feb 2020
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia
- ClinicalTrials.gov ID
- NCT04289051
- Acronym / sponsor ID
- CLP-2020-02-01-1
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 24 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.
This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HYDRAL Oral Rinse | Experimental | Device: HYDRAL Oral Rinse, Device: BIOTENE® Oral Rinse, Device: Placebo Oral RinseSubjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
| BIOTENE® Oral Rinse | Active comparator | Device: HYDRAL Oral Rinse, Device: BIOTENE® Oral Rinse, Device: Placebo Oral RinseSubjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
| Placebo Oral Rinse | Placebo comparator | Device: HYDRAL Oral Rinse, Device: BIOTENE® Oral Rinse, Device: Placebo Oral RinseSubjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have read, understood and signed an informed consent prior to being entered into the study.
- Must be 18 to 80 years of age, male or female.
- Have at least 20 natural or restored teeth.
- Have an unstimulated salivary flow rate <0.20 ml/minute which represents a significant reduction of normal salivary function
- Must have subjective xerostomia symptom: minimum level of 4 on a 10 centimeters Visual Analog Scale (VAS) [How would you score dryness of your mouth?]
Key exclusion criteria (19 listed)
- Physical limitations or restrictions that might preclude normal tooth brushing.
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Presence of severe gingivitis with 30 or more sites showing bleeding on probing.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
- Chronic disease with concomitant oral manifestations other than xerostomia
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 |
|---|---|---|
| HYDRAL Oral RinseApplication 4 times a day for two weeks | Device | BIOTENE® Oral Rinse, HYDRAL Oral Rinse, Placebo Oral Rinse |
| BIOTENE® Oral RinseApplication 4 times a day for two weeks | Device | BIOTENE® Oral Rinse, HYDRAL Oral Rinse, Placebo Oral Rinse |
| Placebo Oral RinseApplication 4 times a day for two weeks | Device | BIOTENE® Oral Rinse, HYDRAL Oral Rinse, Placebo Oral Rinse |
Primary outcome
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline
Time frame: Baseline, 14 days
100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome.
Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline
Time frame: Baseline, 14 days
Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15).
2 secondary outcomes
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline
Time frame: Baseline, 14 days
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline
Time frame: Baseline, 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYDRAL Oral Rinse and BIOTENE® Oral Rinse in people with Xerostomia, run by Sunstar Americas 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 24 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline (time frame: Baseline, 14 days). The study lists 2 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 24 Feb 2022.