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

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Flurbiprofen; Drug: Chlorhexidine

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 9602
    • Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flurbiprofen Chip	Drug: Flurbiprofen; 2.0 mg
Active Comparator: Chlorhexidine chip	Drug: Chlorhexidine; 2.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Probing Pocket Depth reduction	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical attachment levels (CAL) and bleeding on probing (BOP)	8 weeks

Collaborators and Investigators

• Sponsor: Dexcel Pharma Technologies Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 27, 2009
• First Submitted That Met QC Criteria: December 28, 2009
• First Posted (Estimate): December 29, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 5, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Subjects, age>21, with Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal; pockets of 5-9 mm in depth demonstrating bleeding on probing without involving the; apex of the tooth and confirmed by dental X-ray.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Disinfectants; Chlorhexidine; Flurbiprofen
• Other Study ID Numbers: CLI/012F