The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
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ClinicalTrials.gov Identifier: NCT00425451 |
Recruitment Status :
Completed
First Posted : January 23, 2007
Last Update Posted : June 14, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Periodontitis | Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip | Phase 2 |
This is an 80 subjects, single-center, randomized, double-blinded, parallel, 4-arm clinical study (25 subjects in the PerioChip Plus and PerioChip arms and 15 subjects in the Flurbiprofen Chip and Placebo Chip arms).
At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 24.
PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: PerioChip Plus |
Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip |
Experimental: Flurbiprofen Chip |
Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip |
Active Comparator: PerioChip |
Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip |
Placebo Comparator: Placebo Chip |
Drug: PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip |
- At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected [ Time Frame: 24 weeks ]
- PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18. [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent form
- Good general health
- Male or female subjects aged >25 years old
- Minimum of 8 natural teeth
- Availability for the 25 weeks duration of the study
- Periodontal disease on a natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 6-9 mm in depth (target teeth) in order to reach baseline (day 1) with periodontal pockets of 5-8 mm in depth, without involving the apex of the tooth.
- Females of childbearing potential must be non pregnant at entry and agree to use an adequate method of birth control during the study.
- Demonstrate bleeding on probing to the base of the pocket at the pockets (sites) selected at the time of screening.
Exclusion Criteria:
- Presence of oral local mechanical factors that could (in the opinion of the investigator) influences the outcome of the study.
- Presence of orthodontic appliances or any removable appliance that impinges on the tissues being assessed.
- Soft or hard tissue tumours of the oral cavity.
- Presence of dental implant adjacent to target tooth.
- Periodontal pockets of more than 9 mm in depth.
- General systemic antibiotics therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and through out the study duration.
- History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
- Subjects taking diphenylhydantoin, nifedepine and/or cyclosporine, which might influence the pattern of tissue response.
- Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and through out the study duration.
- Pregnant women or those planning to become pregnant or lactating women.
- Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis and related oral pathologies.
- The presence of any medical or psychiatric condition or any other 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 through out the study duration.
- Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425451
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Aubrey Soskolne, Professor | Hadassah Medical Organization IRB |
Responsible Party: | Dr. Avi Avramoof/ V.P R&D, Dexcel Pharma Technologies Ltd. |
ClinicalTrials.gov Identifier: | NCT00425451 |
Other Study ID Numbers: |
CLI/006P |
First Posted: | January 23, 2007 Key Record Dates |
Last Update Posted: | June 14, 2011 |
Last Verified: | June 2011 |
Periodontitis Dental Care Efficacy Safety |
Periodontitis Chronic Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases Chlorhexidine Chlorhexidine gluconate Flurbiprofen Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |