Back to resultsPeriodontal Disease Treatment of a Physically Challenged Population (PDT)
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
metronidazole-nystatin oral rinse
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring periodontal disease, bleeding on probing, periodontal pockets, disabled
Eligibility Criteria
Inclusion Criteria:
Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -
Exclusion Criteria:
Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant
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Sites / Locations
- Toronto Rehabilitation Institute, Dental Department
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Metronidazole-nystatin oral rinse, regular oral hygiene
Arm Description
Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.
Outcomes
Primary Outcome Measures
Evidence of healing of periodontal tissues as shown by a reduction of bleeding
Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01718912
Brief Title
Periodontal Disease Treatment of a Physically Challenged Population
Acronym
PDT
Official Title
The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oravital Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body.
Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
periodontal disease, bleeding on probing, periodontal pockets, disabled
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole-nystatin oral rinse, regular oral hygiene
Arm Type
Other
Arm Description
Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.
Intervention Type
Drug
Intervention Name(s)
metronidazole-nystatin oral rinse
Primary Outcome Measure Information:
Title
Evidence of healing of periodontal tissues as shown by a reduction of bleeding
Description
Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -
Exclusion Criteria:
Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant
-
Facility Information:
Facility Name
Toronto Rehabilitation Institute, Dental Department
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Periodontal Disease Treatment of a Physically Challenged Population
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