Status:
COMPLETED
The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis
Lead Sponsor:
Dexcel Pharma Technologies Ltd.
Conditions:
Generalized Adult Periodontitis
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis...
Eligibility Criteria
Inclusion
- Signed and dated Informed Consent Form.
- Good general health.
- Male or female patients aged \>21 years old.
- Availability for the 25 week duration of the study.
- Chronic periodontal disease on natural teeth
- Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
Exclusion
- Oral health or factor that may influence the outcome of the study.
- History of allergy to Chlorhexidine .
- Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis.
- Patients treated with medications that may influence the outcome of the study.
- Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
- The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01249846
Start Date
December 1 2010
Last Update
January 17 2013
Active Locations (1)
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1
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel, 9602