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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:
ClinicalTrials.gov Identifier:
NCT01249846
First Posted: November 30, 2010
Last Update Posted: January 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dexcel Pharma Technologies Ltd.
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 28, 2010
First Posted: November 30, 2010
Last Update Posted: January 17, 2013
Last Verified: January 2013

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