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

NCT01040286 | Completed Phase 2

• 1 other identifier: CLI/012F
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

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.

Outcome Measures

Primary Outcomes (1)

• Mean Probing Pocket Depth reduction

  8 weeks

Secondary Outcomes (1)

• clinical attachment levels (CAL) and bleeding on probing (BOP)

  8 weeks

Study Arms (2)

Flurbiprofen Chip

EXPERIMENTAL

Drug: Flurbiprofen

Chlorhexidine chip

ACTIVE COMPARATOR

Drug: Chlorhexidine

Interventions

Flurbiprofen DRUG

2.0 mg

Flurbiprofen Chip

Chlorhexidine DRUG

2.5mg

Chlorhexidine chip

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexcel Pharma Technologies Ltd.: lead

Study Sites (1)

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Haifa, 9602, Israel

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Flurbiprofen; Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2009
• First Posted: December 29, 2009
• Study Start: August 1, 2009
• Study Completion: June 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

IL (1)