The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis
This study has been completed.
Sponsor:
Dexcel Pharma Technologies Ltd.
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
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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:
Drug Information available for:
Chlorhexidine
Flurbiprofen
Chlorhexidine gluconate
Flurbiprofen sodium
Hibiclens
U.S. FDA Resources
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:
- Signed and dated informed consent form
- Good general health
- Male or female subjects aged >21 years old
- Availability for the 9 week duration of the study
- 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.
- 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:
- An existing aggressive periodontitis.
- Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.
- Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.
- Soft or hard tissue tumours of the oral cavity.
- Presence of dental implant adjacent to target tooth.
- Presence of more than 2 adjacent periodontal pockets on the same potential target tooth.
- Periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth.
- Systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
- History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
- Subjects taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
- Subjects treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration.
- Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies.
- 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.
- Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
- Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
Contacts and Locations
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 Chlorhexidine Chlorhexidine gluconate Flurbiprofen Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants |
Dermatologic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013