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

NCT ID: NCT04323384

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-01

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.

Detailed Description

Saliva is important for maintaining oral and general health. This complex bioactive substance serves many functions including i) protecting the oral mucosa, ii) reducing demineralization and facilitating remineralization of teeth, and iii) sustaining a balanced oral biome and facilitating antimicrobial actions and clearance of pathogens. Moreover, saliva also plays a critical role in alimentary functions such as mastication and swallowing.

The role of saliva in the process of mastication and swallowing is complex and is not currently well understood. The purpose of mastication is to process food in the oral cavity into a bolus that can be transported through the oropharynx, swallowed safely, and then easily digested. During mastication, ingested food particles are mechanically reduced in size through the process of lingual particle selection and fragmentation between the occlusal surfaces of the teeth. The secretion of saliva is critical for effective mastication, bolus formation and bolus transport. There is also evidence to suggest that the volume of saliva secreted into the oral cavity during alimentation may impact swallowing biomechanics.

Oral tissue dryness is a complex issue. Hyposalivation and xerostomia span numerous clinical pathologies and are known side effects of many therapeutic agents. Hyposalivation occurs when there are objective signs of a reduction of the amount of saliva produced by the salivary glands and can be measured using sialometry. Xerostomia refers to the subjective symptoms of dry mouth and can only be assessed through a person's perception of the presence of symptoms. A person may experience xerostomia with or without hyposalivation or experience hyposalivation with or without xerostomia. Hyposalivation is a commonly complaint in older adults. Additionally, patients with hyposalivation and xerostomia frequently report symptoms of dysphagia, or difficulty swallowing.

To alleviate symptoms associated with hyposalivation, such as the perception of dry mouth, or xerostomia, many people use over-the-counter artificial saliva products such as Biotene® Oral Balance Moisturizing Gel (Biotene). There is, however, a paucity of evidence examining the effect of these products on oral health-related quality of life, mastication, and swallowing. The goal of this study therefore, is to compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene) with the effects of a sham condition on oral health-related quality of life, masticatory efficiency, and perceived swallowing effort 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.

It is hypothesized that, following the application of Biotene® Oralbalance Moisturizing Gel, all groups of participants will experience improved oral health-related quality of life, improved masticatory efficiency a reduction in perceived swallowing effort. The reduction will be significant when compared with that of the sham condition. Participants with xerostomia and/or hyposalivation will demonstrate greater improvement in oral health-related quality of life, improvement in masticatory efficiency, and reduction in perceived swallowing effort compared with those who do not experience xerostomia and/or hyposalivation.

Conditions

Xerostomia; Hyposalivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Biotene® followed by Sham

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.

Group Type: EXPERIMENTAL

Biotene® Oralbalance Moisturizing Gel

Intervention Type: DEVICE

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

Sham followed by Biotene®

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.

Group Type: EXPERIMENTAL

Biotene® Oralbalance Moisturizing Gel

Intervention Type: DEVICE

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

Interventions

Biotene® Oralbalance Moisturizing Gel

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Rebecca

Assistant Professor, Co-Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leigha Rock, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority/Dalhousie University

Central Contacts

Leigha Rock, PhD

Role: CONTACT

leigha.rock@dal.ca

902.494.8864

Rebecca H Affoo, PhD

Role: CONTACT

rebecca.affoo@dal.ca

902.494.5154

Other Identifiers

23677

Identifier Type: -

Identifier Source: org_study_id