BonyPid-500TM Bone Graft Substitute Study

NCT02531100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-06-26

No results posted yet for this study

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.

Conditions

  • Peri Implantitis

Interventions

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)

Sponsors & Collaborators

  • MIS Implant Technologies, Ltd

    collaborator INDUSTRY
  • PolyPid Ltd.

    lead INDUSTRY

Principal Investigators

  • Olga Belotserkovsky · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531100 on ClinicalTrials.gov