Periodontal Disease Treatment of a Physically Challenged Population

Periodontal Disease Clinical Trial

— PDT  

Official title:

The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01718912
• Other study ID #: OVTRI
• Secondary ID: TRI
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 30, 2012
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2012
• Source: Oravital Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Drug:
• metronidazole-nystatin oral rinse

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute, Dental Department	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Oravital Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two weeks	No