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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02201745
Other study ID # FMD-UdeM-EE-2012a
Secondary ID
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


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
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