The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel
The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center
Tel Aviv, Israel
Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe. Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition
Time frame: Baseline to Week 24
Clinical Attachment Levels (CAL)
Loss of attachment is defined as the distance in millimetres that the base of the pocket has migrated apically from the gingival margin of the crown. CAL was calculated at the same site that PPD was measured
Time frame: Baseline to Week 24
Bleeding on Probing (BOP)
BOP was measured at the same site after measuring the PPD. The scoring system used for recording the BOP was a dichotomous one: 0 = No bleeding 1 = Bleeding on probing of the pocket base
Time frame: Baseline to Week 24
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