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The Horizontal Ridge Augmentation Using Equine Xenograft and a Collagenated Porcine Cortical Lamina

NCT04376060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-10-12

Study results available
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Summary

The primary aim of this study is to clinically, radiographically and histologically evaluate the lateral bone augmentation of the soft porcine cortical lamina (OsteoBiol®) using equine-derived bone particles (OsteoBiol®)

Conditions

  • Horizontal Ridge Deficiency

Interventions

DEVICE

Gen-Os®; The soft lamina (OsteoBiol®)

The xenograft used in this study was the Gen-Os® by OsteoBiol; as described by the manufacturer, it is a carbonated nanocrystal bone mineral and collagen of natural heterologous origin, obtained by the treatment of cortical bone tissue of equine origins. Its granulometry ranges between 0.25 to 1 mm and it is described as being slightly radiopaque. The soft lamina (OsteoBiol®) used is a 35x35mm medium curved membrane of porcine origins. Its clinical indications as described by the fabricator: a co-adjuvant for the reconstruction or the partial or complete recovery of lost bone portions, fillers of non-infected, non-sclerotic and well blood bedewed bone defects.

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Carole Chakar, PhD · Saint-Joseph University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
27 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Lebanon

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 NCT04376060 on ClinicalTrials.gov