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Periodontal Disease Treatment of a Physically Challenged Population

The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01718912
Acronym
PDT
Enrollment
11
Registered
2012-10-31
Start date
2013-11-30
Completion date
2014-10-31
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease

Keywords

periodontal disease, bleeding on probing, periodontal pockets, disabled

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).

Interventions

DRUGmetronidazole-nystatin oral rinse

Sponsors

Oravital Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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 \-

Design outcomes

Primary

MeasureTime frameDescription
Evidence of healing of periodontal tissues as shown by a reduction of bleedingtwo weeksEvidence of healing of periodontal tissues is assessed by measuring bleeding points and periodontal pocket depth using a dental probe.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026