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

NCT04323384 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-26

No results posted yet for this study

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

Interventions

DEVICE

Biotene® Oralbalance Moisturizing Gel

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

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Leigha Rock, PhD · Nova Scotia Health Authority/Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-09-01
Completion
2021-12-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323384 on ClinicalTrials.gov