Study of Collagen Membrane in Guided Bone Regeneration

Periimplantitis Clinical Trial

— GBR  

Official title:

Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00454038
• Other study ID #: ae-01.CTIL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 28, 2007
• Last updated: July 9, 2009
• Start date: June 2007
• Est. completion date: May 2009

Study information

• Verified date: January 2009
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Emad K Ailabouni, D.M.D
• Phone: (972)46652429
• Email: emadniss[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystectomy
• Peri-Implantitis
• Periimplantitis
• Root Amputation and Apicoectomy
• Segmental Growing of Alveolar Tissue
• Sinus Lift

Intervention

Device:
• HYPRO SORB F
resorbable, double layered, collagen membrane

Locations

Country	Name	City	State
Israel	The Baruch Padeh Medical Center, Poriya	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expected		2 years	No