The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis

NCT ID: NCT01040286

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Flurbiprofen Chip

Group Type: EXPERIMENTAL

Flurbiprofen

Intervention Type: DRUG

2.0 mg

Chlorhexidine chip

Group Type: ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type: DRUG

2.5mg

Interventions

Flurbiprofen

2.0 mg

Intervention Type: DRUG

Chlorhexidine

2.5mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent form

2. Good general health

3. Male or female subjects aged >21 years old

4. Availability for the 9 week duration of the study

5. Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental X-ray.

6. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method (Oral or parenteral hormonal contraceptive; Intrauterine device; barrier and spermicide) of birth control during the study.

Exclusion Criteria

1. An existing aggressive periodontitis.

2. Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.

3. Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.

4. Soft or hard tissue tumours of the oral cavity.

5. Presence of dental implant adjacent to target tooth.

6. Presence of more than 2 adjacent periodontal pockets on the same potential target tooth.

7. Periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth.

8. Systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.

9. History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).

10. Subjects taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.

11. Subjects treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration.

12. Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies.

13. The presence of any medical or psychiatric condition that in the opinion of the investigator could affect the successful participation of the subject in the study.

14. Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.

15. Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexcel Pharma Technologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Dexcel Pharma Technologies Ltd.

Locations

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

Haifa, , Israel

Countries

Israel

Other Identifiers

CLI/012F

Identifier Type: -

Identifier Source: org_study_id