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OpenTrials
Completed

NCT Number: NCT01718912

Periodontal Disease Treatment of a Physically Challenged Population

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute, Dental Department

Toronto, Ontario, M5G 2A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

metronidazole-nystatin oral rinse

Drug

Primary outcomes

  1. Evidence of healing of periodontal tissues as shown by a reduction of bleeding

    Time frame: two weeks

    Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.

Sponsors and collaborators

Lead sponsor

Oravital Inc

Industry

Registry information

Official study title

The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Acronym: PDT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2012
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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