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Periodontal Disease Treatment of a Physically Challenged Population

Information source: Oravital Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Periodontal Disease

Intervention: metronidazole-nystatin oral rinse (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Oravital Inc


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).

Clinical Details

Official title: The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Evidence of healing of periodontal tissues as shown by a reduction of bleeding


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


Locations and Contacts

Toronto Rehabilitation Institute, Dental Department, Toronto, Ontario M5G 2A2, Canada; Not yet recruiting
Robert Schlosser, DDS, Phone: 416 5973422, Ext: 3048, Email: Robert.Schlosser@uhn.ca
Robert Schlosser, DDS, Principal Investigator
Additional Information

Starting date: November 2012
Last updated: October 30, 2012

Page last updated: August 23, 2015

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