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

Launched by DEXCEL PHARMA TECHNOLOGIES LTD. · Dec 28, 2009

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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.