The Effect of Palatal Brushing on Denture Stomatitis
Primary Purpose
Denture Stomatitis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Palatal brushing
Sponsored by
About this trial
This is an interventional treatment trial for Denture Stomatitis focused on measuring Denture stomatitis, Denture Plaque, Oral Candidiasis, Oral Hygiene
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.
Sites / Locations
- University of Sao Paulo - Ribeirão Preto Dental School
- Faculté de Médecine Dentaire, Université de Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Palatal brushing
Arm Description
Palatal brushing after each meal for 3 months.
Outcomes
Primary Outcome Measures
Palatal Inflammation
Modified Newton classification 0: Healthy mucosa
1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation
Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index
0: Normal tissue
Mild inflammation
Moderate inflammation
Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)
Secondary Outcome Measures
Candida Species Count
Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.
Full Information
NCT ID
NCT01643876
First Posted
July 16, 2012
Last Updated
December 23, 2013
Sponsor
Université de Montréal
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01643876
Brief Title
The Effect of Palatal Brushing on Denture Stomatitis
Official Title
Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture Stomatitis
Keywords
Denture stomatitis, Denture Plaque, Oral Candidiasis, Oral Hygiene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palatal brushing
Arm Type
Experimental
Arm Description
Palatal brushing after each meal for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Palatal brushing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Palatal Inflammation
Description
Modified Newton classification 0: Healthy mucosa
1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation
Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index
0: Normal tissue
Mild inflammation
Moderate inflammation
Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Candida Species Count
Description
Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elham Emami, DDS, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raphael F de Souza, DDS, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo - Ribeirão Preto Dental School
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Faculté de Médecine Dentaire, Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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The Effect of Palatal Brushing on Denture Stomatitis
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