Periodontal Disease Treatment of a Physically Challenged Population (PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718912
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Periodontal Disease Drug: metronidazole-nystatin oral rinse

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease
Study Start Date : November 2013
Primary Completion Date : September 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718912

Canada, Ontario
Toronto Rehabilitation Institute, Dental Department
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Oravital Inc

Responsible Party: Oravital Inc Identifier: NCT01718912     History of Changes
Other Study ID Numbers: OVTRI
TRI ( Other Identifier: Toronto Rehabilitation Institute )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oravital Inc:
periodontal disease
bleeding on probing
periodontal pockets

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Antifungal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action