Completed

Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis

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What is being tested

Palatal brushing

Behavioral
Who is being recruted

Bacterial Infections and Mycoses+6

+ Candidiasis

+ Candidiasis, Oral

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorUniversité de Montréal
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers. However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa. After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes). Tested Hypotheses: * There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing. * There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.

Official TitlePhase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
NCT01643876NCT02201745
Principal SponsorUniversité de Montréal
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesCandidiasisCandidiasis, OralInfectionsStomatognathic DiseasesMouth DiseasesMycosesStomatitisStomatitis, Denture

Criteria

4 inclusion criteria required to participate
Good general health.

Completely edentulous maxilla.

Currently wearing complete upper dentures.

A clinical diagnosis of denture stomatitis.

4 exclusion criteria prevent from participating
Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.

Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.

Previous palatal brushing habit.

Changing of the existing prosthesis during the trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Palatal brushing after each meal for 3 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

University of Sao Paulo - Ribeirão Preto Dental School

Ribeirão Preto, BrazilOpen University of Sao Paulo - Ribeirão Preto Dental School in Google Maps
Suspended

Faculté de Médecine Dentaire, Université de Montréal

Montreal, Canada
Completed2 Study Centers