Periodontal Disease Treatment of a Physically Challenged Population (PDT)

The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

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).

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Drug: metronidazole-nystatin oral rinse

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2A2
      • Toronto Rehabilitation Institute, Dental Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oravital Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: periodontal disease; disabled; periodontal pockets; bleeding on probing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Bacterial Agents; Membrane Transport Modulators; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Ionophores; Metronidazole; Nystatin
• Other Study ID Numbers: OVTRI; TRI (Other Identifier: Toronto Rehabilitation Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No