Periodontal Disease Treatment of a Physically Challenged Population

Not Applicable

Completed

• Conditions: Periodontal Disease
• Interventions: Drug: metronidazole-nystatin oral rinse

• Registration Number: NCT01718912
• Lead Sponsor: Oravital Inc

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Study Start: 2013-11
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metronidazole-nystatin oral rinse, regular oral hygiene	metronidazole-nystatin oral rinse	Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.

Primary Outcome Measures

Name	Time	Method
Evidence of healing of periodontal tissues as shown by a reduction of bleeding	two weeks	Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.

Trial Locations

Locations (1)

Toronto Rehabilitation Institute, Dental Department; 🇨🇦 Toronto, Ontario, Canada