Clinical trial NCT04323384: The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing
Official title: The Effect of Biotene® Oralbalance Moisturizing Gel on the Symptoms of Xerostomia and the Efficiency and Ease of Mastication and Swallowing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Hyposalivation
Keywords: swallowing
saliva
oral health
mastication
quality of life
artificial saliva
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2020-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Perceived Swallowing Effort after application of Biotene®/Sham
timeFrame: baseline, after application of Biotene®/sham
Secondary outcomes:
measure: Change in Spontaneous Swallowing Frequency after application of Biotene®/Sham
timeFrame: baseline, after application of the Biotene®/sham
measure: Change in the Test of Masticating and Swallowing Solids (TOMASS) after application of Biotene®/Sham
timeFrame: baseline, after application of the Biotene®/sham
measure: Change in the Effectiveness of Mastication and Swallowing after application of Biotene®/Sham
timeFrame: baseline, after application of the Biotene®/sham
measure: Change in Oral Health-Related Quality of Life after application of the Biotene®/sham
timeFrame: baseline, after application of the Biotene®/sham condition, half hour increments until responses revert to baseline
Other outcomes:
Locations:
Study officials:
affiliation: Nova Scotia Health Authority/Dalhousie University
name: Leigha Rock, PhD
role: PRINCIPAL_INVESTIGATOR
References: