The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
- Conditions
- Peri-implantitisTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2013-000383-28-DE
- Lead Sponsor
- Dexcel Pharma Technologies Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 246
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): At week 24, compared to baseline, the mean probing Pocket Depth (PD) reductions (absolute change) for the selected target implant/s will be used as the primary efficacy endpoint.;Timepoint(s) of evaluation of this end point: For the Primary End point the time-point for evaluation is the Last study visit (week 24).;Main Objective: To assess the efficacy of Chlorhexidine gluconate chip (PerioChip®) versus Subgingival debridement in Peri-implantitis patients.;Secondary Objective: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • PD measurement at week 24 compared to baseline in patients with baseline PD measurement of 6-8 mm inclusive.<br>• Bleeding on Probing (BOP) measurements at week 16 and 24 compared to baseline.<br>• PD measurement at week 16 compared to baseline.<br>;Timepoint(s) of evaluation of this end point: For the Secondary End point the time-point for evaluation will be week 24 and week 16.