Periodontal Disease Treatment of a Physically Challenged Population (PDT)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Periodontal Disease |
Drug: metronidazole-nystatin oral rinse |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
-
Contacts and Locations| Canada, Ontario | |
| 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 | |
More Information
No publications provided
| Responsible Party: | Oravital Inc |
| ClinicalTrials.gov Identifier: | NCT01718912 History of Changes |
| Other Study ID Numbers: | OVTRI, TRI |
| Study First Received: | October 29, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Oravital Inc:
|
periodontal disease bleeding on probing periodontal pockets |
Additional relevant MeSH terms:
|
Periodontal Diseases Mouth Diseases Stomatognathic Diseases Metronidazole Nystatin Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents |
Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Antifungal Agents Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013