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

NCT ID: NCT01249846

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Brief Summary

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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

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Conditions

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Generalized Adult Periodontitis

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

PerioChip ®

Intervention Type DRUG

Arm 2

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

Group Type PLACEBO_COMPARATOR

PerioChip ®

Intervention Type DRUG

Interventions

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PerioChip ®

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dexcel Pharma Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Dexcel Pharma Technologies Ltd.

Locations

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

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLI/015P

Identifier Type: -

Identifier Source: org_study_id

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