The Effect of Palatal Brushing on Denture Stomatitis

NCT01643876 | Completed Phase 1 Results DMC

• 1 other identifier: FMD-UdeM-EE-2012a
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

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

Keywords

Denture stomatitis; Denture Plaque; Oral Candidiasis; Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Palatal Inflammation

  Modified Newton classification 0: Healthy mucosa 1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation 1. Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue 2. Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue 3. Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index 0: Normal tissue 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)

  3 months

Secondary Outcomes (1)

• Candida Species Count

  3 months

Study Arms (1)

Palatal brushing

EXPERIMENTAL

Palatal brushing after each meal for 3 months.

Behavioral: Palatal brushing

Interventions

Palatal brushing 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.

Palatal brushing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• University of Sao Paulo: collaborator

Study Sites (2)

University of Sao Paulo - Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, Brazil

Location

Faculté de Médecine Dentaire, Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Stomatitis, Denture; Candidiasis, Oral

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

One group pre-test post-test study. External validity limitations

Results Point of Contact

• Title: Dr. Elham Emami
• Organization: Université de Montréal

elham.emami@umontreal.ca

5143436111

Study Officials

• Elham Emami, DDS, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Raphael F de Souza, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D.D.S., M. Sc., Ph. D, Assistant Professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 22, 2014
• Results First Posted: January 22, 2014

Record last verified: 2013-12

Locations

BR (1); CA (1)