The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing

NCT04323384 | Unknown FDA Device

• 1 other identifier: 23677
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene), an over-the-counter artificial saliva, that the effects of a sham condition on oral health-related quality of life, mastication, and swallowing in four groups of participants: 1) Participants not experiencing xerostomia or hyposalivation, 2) Participants experiencing xerostomia and hyposalivation, 3) Participants experiencing xerostomia but not hyposalivation, 4) Participants experiencing hyposalivation but not xerostomia.

Conditions

Xerostomia; Hyposalivation

Keywords

swallowing; saliva; oral health; mastication; quality of life; artificial saliva

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Swallowing Effort after application of Biotene®/Sham

  Participants will be instructed to swallow and use a visual analog scale to rate the perceived swallowing effort by bisecting a 100mm line anchored with "no effort" and "extreme effort" (higher scores indicate a worse outcome). After the experimental or sham condition has been applied, participants will re-rate their perceived swallowing effort.

  baseline, after application of Biotene®/sham

Secondary Outcomes (4)

• Change in Spontaneous Swallowing Frequency after application of Biotene®/Sham

  baseline, after application of the Biotene®/sham

• Change in the Test of Masticating and Swallowing Solids (TOMASS) after application of Biotene®/Sham

  baseline, after application of the Biotene®/sham

• Change in the Effectiveness of Mastication and Swallowing after application of Biotene®/Sham

  baseline, after application of the Biotene®/sham

• Change in Oral Health-Related Quality of Life after application of the Biotene®/sham

  baseline, after application of the Biotene®/sham condition, half hour increments until responses revert to baseline

Study Arms (2)

Biotene® followed by Sham

EXPERIMENTAL

Recruited volunteers will each participate in two experimental sessions. Participants will be randomized into either Protocol A or Protocol B. In their first session, participants in Protocol A will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the experimental condition. For the experimental condition, participants will be instructed to apply Biotene® Oralbalance Moisturizing Gel according to package directions. Testing will then be repeated. In the second session, after baseline testing, participants will receive the sham condition (instead of the experimental condition). For the sham condition, participants will be instructed to rinse their mouth with room temperature distilled water. Testing will then be repeated.

Device: Biotene® Oralbalance Moisturizing Gel

Sham followed by Biotene®

EXPERIMENTAL

Recruited volunteers will each participate in two experimental sessions. Participants will be randomized into two protocols: 1) Protocol A and 2) Protocol B. In their first session, participants in Protocol B will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the sham condition. Testing will then be repeated. In the second session, after baseline testing, participants will receive the experimental condition (instead of the sham condition). Testing will then be repeated.

Device: Biotene® Oralbalance Moisturizing Gel

Interventions

Biotene® Oralbalance Moisturizing Gel DEVICE

Biotene® Oralbalance Moisturizing Gel will be applied to the oral cavity according to the package directions.

Biotene® followed by Sham; Sham followed by Biotene®

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable adults
• Age 19 years of age or older
• Able to sit upright independently and transfer to a chair
• Able to eat foods requiring mastication
• Decision-making capacity to provide informed consent

You may not qualify if:

• Acute illness or uncontrolled medical condition
• Allergies to any pharmaceuticals
• Allergies to medical tape/adhesive
• Allergies to Nabisco Saltines® or any of the ingredients
• Participant-reported issues with excess saliva and/or drooling
• Open ulcerations in the oral cavity.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Leigha Rock, PhD

  Nova Scotia Health Authority/Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigha Rock, PhD

CONTACT

902.494.8864; leigha.rock@dal.ca

Rebecca H Affoo, PhD

CONTACT

902.494.5154; rebecca.affoo@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Primary Investigator

Model Details: This project will use a crossover, repeated measures design to test the previously stated hypotheses. The benefits of using this design include improved control of between-subject variability and improved statistical power.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share