CompletedPhase 2

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

IsraelStarted 2009-08

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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.

What they're measuring

Mean Probing Pocket Depth reduction

Timeframe: 8 weeks

Trial details

NCT IDNCT01040286

SponsorDexcel Pharma Technologies Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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