The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis

Dexcel Pharma Technologies Ltd.0 个研究点目标入组 246 人开始时间: 2014年8月7日最近更新: 2021年5月25日

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•1. Signed and dated Informed Consent Form. The patient is of age and is capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the facts.
•2. Male or female patients aged =18 years old.
•3. The patient has at least one implant in the oral cavity with clinical and radiographical signs of peri-implantitis. In the affected implant, at least one of the four aspect measured (mesio-buccal, mid-buccal, disto-buccal and mid-lingual) must show radiographic evidence of bone loss of at least 3 mm from mplant shoulder, and at least 2 mm distal and mesial supporting bone left from the apex to the coronal direction, in combination with bleeding and/or suppuration on probing and a peri-implant Probing Depth (PD) of 5-8 mm.
•4. The implants have been in function more than 2 years.
•5. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. History of allergic reaction to Chlorhexidine.
•2. Active Periodontitis which required definitive treatment.
•3. Presence of soft or hard tissue tumours of the oral cavity.
•4. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration. In case the investigator advises the patient that antibiotic therapy is required during the course of the study, the patient should be excluded from further participation.
•5. Patients with uncontrolled diabetes, of any type, and/or patients with HbA1c test value >7.5% dated 3 months prior to the screening visit.
•6. Drug and alcohol abuse.

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