Study of Collagen Membrane in Guided Bone Regeneration (GBR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00454038
First received: March 28, 2007
Last updated: July 9, 2009
Last verified: January 2009
  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 1
Phase 2

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

Primary Outcome Measures:
  • expected [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: HYPRO SORB F
    resorbable, double layered, collagen membrane
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Tiberias, Israel
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   
Sub-Investigator: Eran D Front, D.M.D         
Sub-Investigator: Zvi A Laster, D.M.D         
Principal Investigator: Emad K Ailabouni, D.M.D         
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Study Chair: Alabuni Emad The Baruch Padeh Medical Center
  More Information

No publications provided

Responsible Party: watad sami, CARDIOPHIL LTD
ClinicalTrials.gov Identifier: NCT00454038     History of Changes
Other Study ID Numbers: ae-01.CTIL
Study First Received: March 28, 2007
Last Updated: July 9, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases

ClinicalTrials.gov processed this record on July 28, 2014