The Effect of Palatal Brushing on Denture Stomatitis

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

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.

Study Overview

• Status: Completed
• Conditions: Denture Stomatitis
• Intervention / Treatment: Behavioral: Palatal brushing

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil
      • University of Sao Paulo - Ribeirão Preto Dental School
• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Faculté de Médecine Dentaire, Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Palatal brushing; Palatal brushing after each meal for 3 months.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue; Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue; Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index 0: Normal tissue; Mild inflammation; Moderate inflammation; Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Candida Species Count	Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.	3 months

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: University of Sao Paulo
• Investigators: Principal Investigator: Elham Emami, DDS, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (ESTIMATE): July 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Oral Hygiene; Denture stomatitis; Oral Candidiasis; Denture Plaque
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Denture
• Other Study ID Numbers: FMD-UdeM-EE-2012a