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Study of Collagen Membrane in Guided Bone Regeneration (GBR)

This study is not yet open for participant recruitment.
Verified by The Baruch Padeh Medical Center, Poriya, June 2007

Sponsored by: The Baruch Padeh Medical Center, Poriya
Information provided by: The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT00454038
  Purpose

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.


Condition Intervention Phase
Cystectomy
Segmental Growing of Alveolar Tissue
Sinus Lift
Root Amputation and Apicoectomy
Periimplantitis
Device: HYPRO SORB F
Phase I
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Estimated Enrollment:   100
Study Start Date:   June 2007
Estimated Study Completion Date:   May 2008

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454038

Contacts
Contact: Emad K Ailabouni, D.M.D     (972)46652429     emadniss@netvision.net.il    
Contact: Rabab R Jarjoura, D.M.D     (972)504358785     rababrj@yahoo.com    

Locations
Israel
The Baruch Padeh Medical Center, Poriya    
      Tiberias, Israel

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya

Investigators
Study Chair:     Alabuni Emad     The Baruch Padeh Medical Center    
  More Information


Study ID Numbers:   ae-01.CTIL
First Received:   March 28, 2007
Last Updated:   June 6, 2007
ClinicalTrials.gov Identifier:   NCT00454038
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by The Baruch Padeh Medical Center, Poriya:
cystectomy  
augmentation  
sinus  
amputation  
implant  

ClinicalTrials.gov processed this record on October 22, 2008




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