Periodontal Disease Treatment of a Physically Challenged Population

NCT01718912 | Completed

• 2 other identifiers: OVTRITRI
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontal Disease

Keywords

periodontal disease; bleeding on probing; periodontal pockets; disabled

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Metronidazole-nystatin oral rinse, regular oral hygiene

OTHER

Week 1: daily brushing with suction brush. Week two: daily brushing with a mixture of metronidazole-nystatin suspension.

Drug: metronidazole-nystatin oral rinse

Interventions

metronidazole-nystatin oral rinse DRUG

Metronidazole-nystatin oral rinse, regular oral hygiene

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Oravital Inc: lead

Study Sites (1)

Toronto Rehabilitation Institute, Dental Department

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)