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Sinus Floor Elevation Using Alpha-Bio's GRAFT Natural Bovine Bone vs. Commercially Available Bone Graft

NCT02384291 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-07-16

No results posted yet for this study

Summary

This clinical study is designed to compare the regenerative outcome of using separately two different Xenografts during sinus floor augmentation.

Aim of this prospective randomized-controlled clinical trial is to compare the regenerative results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft after two-step sinus floor elevations by clinical and histological analysis.

Clinical Parameters are wound healing parameters, radiological volume stability and implant survival rates. Histological parameters are based on a histomorphometrical analysis of trephine cores harvested in progress of implant bed preparation.

Conditions

  • Sinus Floor Augmentation

Interventions

DEVICE

Alpha-Bio GRAFT Natural Bovine Bone

Pure Hydroxyapatite ceramic mineral with high similarity to the human bone

DEVICE

natural bone substitute

natural bone substitute material derived from the mineral portion of bovine bone

Sponsors & Collaborators

  • Alpha - Bio Tec Ltd.

    lead INDUSTRY

Principal Investigators

  • Daniel Rothamel, Priv-Doz Dr. · Department of Craniomaxillofacial and Plastic Surgery University Hospital of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-12-31
Completion
2020-06-30

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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 NCT02384291 on ClinicalTrials.gov