Study of Collagen Membrane in Guided Bone Regeneration

Phase 1

• Conditions: Cystectomy; Segmental Growing of Alveolar Tissue; Sinus Lift; Root Amputation and Apicoectomy; Periimplantitis

• Registration Number: NCT00454038
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

Brief Summary

The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.

Detailed Description

Guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. The main function of the membrane barrier in GBR is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. Resorbable and non-resorbable membranes have been used in GBR. While non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. The aim of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.

Study Timeline

• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Study Start: 2007-06
• Primary Completion: 2008-01
• Status Verified: 2009-01
• Study Completion: 2009-05
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cystectomy
• Segmental growing of alveolar tissue
• Lifting of the sinus bottom
• Root amputation
• Apicoectomy
• Filling of the alveolus after resections in prosthetic surgical practice
• Periimplantitis
• Maxillofacial surgery

Exclusion Criteria

• Inside bone fractures when acrylate adhesives are applied.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
expected	2 years

Trial Locations

Locations (1)

The Baruch Padeh Medical Center, Poriya; 🇮🇱 Tiberias, Israel