The Effect of Palatal Brushing on Denture Stomatitis

NCT ID: NCT01643876

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

Conditions

Denture Stomatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palatal brushing

Palatal brushing after each meal for 3 months.

Group Type: EXPERIMENTAL

Palatal brushing

Intervention Type: BEHAVIORAL

Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.

Interventions

Palatal brushing

Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Good general health.
• Completely edentulous maxilla.
• Currently wearing complete upper dentures.
• A clinical diagnosis of denture stomatitis.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Elham Emami

D.D.S., M. Sc., Ph. D, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elham Emami, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Raphael F de Souza, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo - Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, Brazil

Faculté de Médecine Dentaire, Université de Montréal

Montreal, Quebec, Canada

Countries

Brazil; Canada

Other Identifiers

FMD-UdeM-EE-2012a

Identifier Type: -

Identifier Source: org_study_id

NCT02201745

Identifier Type: -

Identifier Source: nct_alias