Periodontal Disease Treatment of a Physically Challenged Population (PDT)
Recruitment status was Not yet recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease|
- Evidence of healing of periodontal tissues as shown by a reduction of bleeding [ Time Frame: two weeks ] [ Designated as safety issue: No ]Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Metronidazole-nystatin oral rinse, regular oral hygiene
Metronidazole-nystatin rinse, 3ml, rinse for 30 seconds and spit out two times a day.
Group 2 will brush twice a day
|Drug: metronidazole-nystatin oral rinse|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718912
|Toronto Rehabilitation Institute, Dental Department||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2A2|
|Contact: Robert Schlosser, DDS 416 5973422 ext 3048 Robert.Schlosser@uhn.ca|
|Principal Investigator: Robert Schlosser, DDS|