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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

Primary Purpose

Generalized Adult Periodontitis

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
PerioChip ®
Sponsored by
Dexcel Pharma Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Adult Periodontitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®.

Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 28, 2010
Last Updated
January 16, 2013
Sponsor
Dexcel Pharma Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01249846
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dexcel Pharma Technologies Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Adult Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment.
Intervention Type
Drug
Intervention Name(s)
PerioChip ®

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
City
Haifa
ZIP/Postal Code
9602
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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