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

Dexcel Pharma Technologies

Status and phase: Completed; Phase 3

Conditions: Generalized Adult Periodontitis

Treatments: Drug: PerioChip ®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249846

CLI/015P

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

0 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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

Treatment:

Drug: PerioChip ®

Arm 2

Placebo Comparator group

Description:

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

Treatment:

Drug: PerioChip ®