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

Generalized Adult Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249846
• Other study ID #: CLI/015P
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2010
• Last updated: January 16, 2013
• Start date: December 2010

Study information

• Verified date: January 2013
• Source: Dexcel Pharma Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Generalized Adult Periodontitis
• Periodontitis

Intervention

Drug:
• PerioChip ®

Locations

Country	Name	City	State
Israel	Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Dexcel Pharma Technologies Ltd.

Country where clinical trial is conducted

Israel,