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

NCT01249846 | Completed Phase 3

• 1 other identifier: CLI/015P
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Adult Periodontitis

Study Arms (2)

Arm 1

EXPERIMENTAL

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 ®

Arm 2

PLACEBO COMPARATOR

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 ®

Interventions

PerioChip ® DRUG

Arm 1; Arm 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexcel Pharma Technologies Ltd.: lead

Study Sites (1)

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

Haifa, 9602, Israel

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 28, 2010
• First Posted: November 30, 2010
• Study Start: December 1, 2010
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

IL (1)