The Effect of Palatal Brushing on Denture Stomatitis

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643876
• Other study ID #: FMD-UdeM-EE-2012a
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2012
• Last updated: December 23, 2013
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	University of Sao Paulo

Countries where clinical trial is conducted

Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No