NCT02531100

BonyPid-500TM Bone Graft Substitute Study

PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: PolyPid Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peri Implantitis

Interventions

Type	Name	Description
DEVICE	BonyPid 500TM implantation concomitantly to SOC treatment	BonyPid 500TM implantation concomitantly to SOC treatment
OTHER	SOC treatment only	Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2015-08-24
• Last updated: 2018-06-26

Locations

2 sites across 1 country: Israel