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

This study has been completed.
Sponsor:
Information provided by:
Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT01040286
First received: December 27, 2009
Last updated: July 5, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Periodontitis
Drug: Flurbiprofen
Drug: Chlorhexidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis

Resource links provided by NLM:


Further study details as provided by Dexcel Pharma Technologies Ltd.:

Primary Outcome Measures:
  • Mean Probing Pocket Depth reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical attachment levels (CAL) and bleeding on probing (BOP) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Study Start Date: August 2009
Study Completion Date: June 2010
Arms Assigned Interventions
Experimental: Flurbiprofen Chip Drug: Flurbiprofen
2.0 mg
Active Comparator: Chlorhexidine chip Drug: Chlorhexidine
2.5mg

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040286

Locations
Israel
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel, 9602
Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.
  More Information

No publications provided

Responsible Party: Avi Avramoff, V.P R&D, Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT01040286     History of Changes
Other Study ID Numbers: CLI/012F
Study First Received: December 27, 2009
Last Updated: July 5, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Dexcel Pharma Technologies Ltd.:
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:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Flurbiprofen
Chlorhexidine
Chlorhexidine gluconate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014