Palatal Brushing for Denture Stomatitis

Dental Plaque Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201745
• Other study ID #: FMD-UdeM-EE-2012a
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: July 25, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Several dental professionals recommend that complete denture wearers should brush their palate. Some advantages include better cleansing and blood flow, which may help to prevent or treat oral infections, such as denture-related stomatitis. However, there is no previous clinical trial dealing on that subject. Therefore, our goal is to evaluate whether palatal brushing may change the severity of denture stomatitis or counts of microbes on dentures and mucosa. After an initial exam and data collection, participants will receive instructions for palatal hygiene and will be assessed following 1 and 3 months. Collected data 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: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Good general health

• Completely edentulous mouth

• Currently wearing complete upper dentures

• A clinical diagnosis of denture stomatitis

Exclusion Criteria:

• Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosupression, chemotherapy and radiotherapy

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

• Previous palatal brushing

• Changing of existing prosthesis during the trial

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Dental Plaque
• Denture Stomatitis
• Oral Candidiasis
• Oral Hygiene
• Stomatitis
• Stomatitis, Denture

Intervention

Behavioral:
• Oral hygiene instructions
Participants will be instructed how to brush the 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
Raphael Freitas de Souza	University of Sao Paulo

Countries where clinical trial is conducted

Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatal inflammation	Quantified by means of (A) a modified Newton classification, and (B) a clinical inflammation index, ranging from 0 to 6.	3 months	No
Secondary	Candida albicans count	C. albicans colony counts obtained from (A) plaque formed on denture surface, and (B) palatal mucosa.	3 months	No