A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water

Study Overview
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Brief Summary
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This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.

Detailed Description
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This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by Modified Dry Mouth Inventory [DMI] score), randomized, parallel group study in participants with self-reported dry mouth symptoms as determined by participant responses to the DMI. Participants used their assigned dry mouth treatment at home for 28 days.

Official Title
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A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water

Conditions
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Xerostomia

Intervention / Treatment
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* Device: Experimental Oralbalance Moisturizing Gel
* Device: Biotene Original Oral Rinse
* Device: Biotene Moisturizing Mouth Spray
* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. Understands and is willing, able and likely to comply with all study procedures and restrictions. Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination., b) Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. Subjects with stable and controlled medical conditions with no overt medical conditions which would contraindicate participation (in the opinion of the Investigator or medically qualified designee) which would interfere with the conduct of the study. Self reported feeling of a dry mouth according to the modified DMI questions. Subject must answer at least 3 out of 5 questions with 'agree a little', 'agree' or 'strongly agree'. Exclusion Criteria: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Women who are breast-feeding. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. Previous participation in this study. Recent history (within the last 1 year) of alcohol or other substance abuse. An employee of the sponsor or the study site or members of their immediate family. Subject works in one of the following: Advertising, Journalism, Public Relations, Manufacturing, retail or distribution of medicines, medical devices or healthcare products, Market Research or Marketing. Use of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth. At the discretion of the examiner, subjects currently under the care of a dental/medical professional specifically for the treatment of dry mouth. Evidence of gross intra-oral neglect or need for extensive dental therapy. Denture wearer (partial or complete dentures). Subject with dental implants. Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration). Subject is currently undergoing radiotherapy and/or chemotherapy treatment. Any condition the investigator identifies that can confound the subject's ability to properly participate in the study e.g. Alzheimer's Disease.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OralBalance moisturizing gel<br>All the participants in this arm used an experimental Oralbalance gel as instructed under the supervision of trained site staff on their visits. | Device: Experimental Oralbalance Moisturizing Gel<br>* Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.<br>|
| Experimental: Oral rinse<br>All the participants in this arm used an Oral rinse as instructed under the supervision of trained site staff on their visits. | Device: Biotene Original Oral Rinse<br>* Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.<br>|
| Experimental: Moisturizing mouth spray<br>All the participants in this arm used a moisturising mouth spray as instructed under the supervision of trained site staff on their visits. | Device: Biotene Moisturizing Mouth Spray<br>* Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.<br>|
| Sham Comparator: Water only use<br>All the participants in this arm used water as instructed under the supervision of trained site staff on their visits. | Other: Water<br>* Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth) | Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment. | At Day 29 of treatment (2 hours after supervised product use) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29 | Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product:1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, and 4 hours after supervised product use on Day 29 of treatment. | At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use) | 
| Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1 | Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 of treatment. | At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use) | 
| Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I) | Participants were asked to use the following scale to rate question (Q) 2 to 12 of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I had following questions Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel 'normal', Q12: Having a cooling sensation. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 and 29 of treatment. Individual score for each question at different tome point was reported for this endpoint. | At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use) | 
| Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8 | Participants were asked to use the following scale to rate questions of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQI had following questions Q1: Relieving the discomfort of dry mouth Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel 'normal', Q12: Having a cooling sensation. PPAQ I was assessed at 2 hours after supervised product use on Day 8 of treatment. | At Day 8 (2 hours after supervised product use) | 
| Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II) | Participants were asked to use the following scale to rate questions of PPAQ II as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ II had following questions; Q1: Providing relief all night, Q2: Reducing the number of times you wake up from dry mouth, Q3: Feeling less parched when you wake up, Q4: Having a long lasting dry mouth relief, Q5. Having a long lasting lubricating effect, Q6: Having a long lasting moisturizing effect. PPAQ II was assessed before supervised product use on Day 8 and 29 of treatment. | At Day 8 and 29 | 
| Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I) | The AUC was calculated for the interval starting at the time of the 30 minute response and ending at the time of the last valid reading using the trapezoidal method on Day 1 and Day 29. AUC was calculated for the score of the individual question of PPAQ1. All the questions were scored using the following scale: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. | At Day 1 and 29 |