NCT04323384

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

The Effect of Biotene® Oralbalance Moisturizing Gel on the Symptoms of Xerostomia and the Efficiency and Ease of Mastication and Swallowing

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2020-03-26
• Last updated: 2020-03-26

Regulatory

• FDA-regulated device study