BonyPid-500TM Bone Graft Substitute Study
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|ClinicalTrials.gov Identifier: NCT02531100|
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : December 7, 2016
This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation for intrabony peri-implantitis defects.
BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline, and is intended for filling and reconstruction of bone defects caused by peri-implantitis.
|Condition or disease||Intervention/treatment||Phase|
|Peri Implantitis||Device: BonyPid 500TM implantation concomitantly to SOC treatment Procedure: SOC treatment only||Not Applicable|
This is a pilot, randomized, single-blind, two arm controlled, multicenter study in subjects undergoing surgical treatment for peri-implantitis disease. Eligible subjects will undergo a surgical treatment and be randomly assigned during surgical intervention (after flap opening) in a 1:1 ratio to adjunct BonyPid-500TM implantation or no BonyPid-500TM implantation.
Randomization will be stratified by site and number of eligible implants, i.e., single or multiple.
The study population includes male and female subjects, 20 - 80 years of age at screening, diagnosed with peri-implantitis and recommended for surgical treatment of peri-implantitis disease.
Up to 77 subjects will be enrolled to this study which will be conducted in two medical centers in Israel.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: BonyPid-500TM implantation
Standard of care (SOC) treatment (Manual and ultrasonic debridement and surface decontamination) followed by BonyPid-500TM implantation.
Device: BonyPid 500TM implantation concomitantly to SOC treatment
BonyPid 500TM implantation concomitantly to SOC treatment
Active Comparator: SOC treatment
Standard of care treatment (Manual and ultrasonic debridement and surface decontamination) only
Procedure: SOC treatment only
Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)
- Safety: AEs (adverse events) as reported by the subject or observed by the Investigator, [ Time Frame: 12 months ]All AEs including any change in medical or dental status.
- Effectiveness: the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm. [ Time Frame: 6 months ]The primary effectiveness endpoint of the study is the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531100
|Contact: Olga Belotserkovsky, Ms.||+972.74.719.5700 ext firstname.lastname@example.org|
|Contact: Ilana Sufaro, Ms.||+972.74.719.5700 ext 157||Ilana.email@example.com|
|Rambam Health Care Campus||Recruiting|
|Haifa, Israel, 3109601|
|Contact: Liron Eliezer, Ms. +972-4-7771636 firstname.lastname@example.org|
|Hadassah Medical Center||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Lior Shapira, Prof. +972-52-251-5190 email@example.com|
|Study Director:||Olga Belotserkovsky||Sponsor GmbH|