Phase 1
N=48
The Effect of Palatal Brushing on Denture Stomatitis
Denture Stomatitis
Bottom Line
View on ClinicalTrials.gov: NCT01643876 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Palatal Inflammation — 3; 3; 2.5; 2 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Palatal brushing (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Université de Montréal
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palatal Inflammation |
3; 3; 2.5; 2; 2; 1 | <0.0001 sig |
| SECONDARY Candida Species Count |
1110; 860; 0; 0 | <0.05 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01643876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.