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The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis

This study has been completed.
Sponsor:
Information provided by:
Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT01249846
First received: November 28, 2010
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Generalized Adult Periodontitis
 Drug: PerioChip ®
 Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dexcel Pharma Technologies Ltd.:

Study Start Date: December 2010
Arms Assigned Interventions
Experimental: Arm 1
Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®.
 Drug: PerioChip ®
Placebo Comparator: Arm 2
Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment.
 Drug: PerioChip ®

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated Informed Consent Form.
  2. Good general health.
  3. Male or female patients aged >21 years old.
  4. Availability for the 25 week duration of the study.
  5. Chronic periodontal disease on natural teeth
  6. 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 Criteria:

  1. Oral health or factor that may influence the outcome of the study.
  2. History of allergy to Chlorhexidine .
  3. Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis.
  4. Patients treated with medications that may influence the outcome of the study.
  5. Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
  6. 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.
  7. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249846

Locations
Israel
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel, 9602
Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.
  More Information

No publications provided

Responsible Party: Dr. Avi Avramoff, V.P R&D, Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT01249846     History of Changes
Other Study ID Numbers: CLI/015P
Study First Received: November 28, 2010
Last Updated: January 16, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013