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

Nova Scotia Health Authority (NSHA)

Status: Unknown

Conditions: Xerostomia; Hyposalivation

Treatments: Device: Biotene® Oralbalance Moisturizing Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04323384

23677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Biotene® followed by Sham

Experimental group

Description:

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.

Treatment:

Device: Biotene® Oralbalance Moisturizing Gel

Sham followed by Biotene®

Experimental group

Description:

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.

Treatment:

Device: Biotene® Oralbalance Moisturizing Gel