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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040286
• Other study ID #: CLI/012F
• Status: Completed
• Phase: Phase 2
• First received: December 27, 2009
• Last updated: July 5, 2010
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Dexcel Pharma Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Flurbiprofen
2.0 mg
• Chlorhexidine
2.5mg

Locations

Country	Name	City	State
Israel	Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Dexcel Pharma Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Probing Pocket Depth reduction		8 weeks	Yes
Secondary	?clinical attachment levels (CAL) and bleeding on probing (BOP)		8 weeks	Yes