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

Phase 3

Completed

• Conditions: Generalized Adult Periodontitis
• Interventions: Drug: PerioChip ®

• Registration Number: NCT01249846
• Lead Sponsor: Dexcel Pharma Technologies Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-28
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Study Start: 2010-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	PerioChip ®	Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®.
Arm 2	PerioChip ®	Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment.

Trial Locations

Locations (1)

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center; 🇮🇱 Haifa, Israel