Dental Plaque Clinical Trial
Verified date | July 2014 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Raphael Freitas de Souza | University of Sao Paulo |
Brazil, Canada,
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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