Peri Implantitis Clinical Trial
Official title:
PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02091609 -
a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants
|
N/A |