The Effect of Palatal Brushing on Denture Stomatitis
This study is currently recruiting participants.
Verified July 2012 by Université de Montréal
Sponsor:
Université de Montréal
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Elham Emami, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01643876
First received: July 16, 2012
Last updated: July 18, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Denture Stomatitis |
Behavioral: Palatal brushing |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Multicenter Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis |
Resource links provided by NLM:
Further study details as provided by Université de Montréal:
Primary Outcome Measures:
- Palatal inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Candida species count [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]Candida spp. colony counts obtained from (A) plaque formed on denture surface, and (B) palatal mucosa.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Palatal brushing
Palatal brushing after each meal for 3 months.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643876
Contacts
| Contact: ELHAM EMAMI, DDS, MSc, PhD | +1(514) 3436053 | elham.emami@umontreal.ca |
| Contact: Rafael DE Souza, DDS, MSc, PhD | raphaelfs@yahoo.com.br |
Locations
| Brazil | |
| University of Sao Paulo - Ribeirão Preto Dental School | Recruiting |
| Ribeirão Preto, São Paulo, Brazil | |
| Contact: Maria Paula Della Vecchia, DDS, MSc +55(16)36024800 | |
| Contact: Viviane C Oliveira, BSc, MSc +55(16)36024800 | |
| Principal Investigator: Raphael F de Souza, DDS, PhD | |
| Sub-Investigator: Maria Paula Della Vecchia, DDS, PhD | |
| Sub-Investigator: Viviane C Oliveira, BSc, MSc | |
| Sub-Investigator: Mauricio Bardaro, DDS | |
| Canada, Quebec | |
| Faculté de Médecine Dentaire, Université de Montréal | Recruiting |
| Montréal, Quebec, Canada | |
| Contact: Elham Emami, DDS, PhD +1(514)343-6053 elham.emami@umontreal.ca | |
| Principal Investigator: Elham Emami, DDS, PhD | |
| Sub-Investigator: Louis de Koninck, DDS, MSc | |
| Sub-Investigator: Jean Barbeau, DDS, PhD | |
Sponsors and Collaborators
Université de Montréal
University of Sao Paulo
Investigators
| Principal Investigator: | Elham Emami, DDS, PhD | Université de Montréal |
| Principal Investigator: | Raphael F de Souza, DDS, PhD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Elham Emami, D.D.S., M. Sc., Ph. D, Assistant Professor, Université de Montréal |
| ClinicalTrials.gov Identifier: | NCT01643876 History of Changes |
| Other Study ID Numbers: | FMD-UdeM-EE-2012a |
| Study First Received: | July 16, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | Canada: Institutional Review Board |
Keywords provided by Université de Montréal:
|
Denture stomatitis Denture Plaque Oral Candidiasis Oral Hygiene |
Additional relevant MeSH terms:
|
Stomatitis Stomatitis, Denture Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013