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

January 16, 2013 updated by: Dexcel Pharma Technologies Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 9602
        • Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 ®

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dexcel Pharma Technologies Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Study Registration Dates

First Submitted

November 28, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI/015P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Generalized Adult Periodontitis

Clinical Trials on PerioChip ®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe