Periodontal Disease Treatment of a Physically Challenged Population (PDT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oravital Inc
ClinicalTrials.gov Identifier:
NCT01718912
First received: October 29, 2012
Last updated: March 29, 2016
Last verified: March 2016
  Purpose

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 Intervention
Periodontal Disease
Drug: metronidazole-nystatin oral rinse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Resource links provided by NLM:


Further study details as provided by Oravital Inc:

Primary Outcome Measures:
  • Evidence of healing of periodontal tissues as shown by a reduction of bleeding [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Evidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.


Enrollment: 11
Study Start Date: November 2013
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718912

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

Responsible Party: Oravital Inc
ClinicalTrials.gov Identifier: NCT01718912     History of Changes
Other Study ID Numbers: OVTRI  TRI 
Study First Received: October 29, 2012
Last Updated: March 29, 2016
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 26, 2016