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Study of Collagen Membrane in Guided Bone Regeneration (GBR)

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ClinicalTrials.gov Identifier: NCT00454038
Recruitment Status : Unknown
Verified January 2009 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Recruiting
First Posted : March 29, 2007
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cystectomy Segmental Growing of Alveolar Tissue Sinus Lift Root Amputation and Apicoectomy Periimplantitis Device: HYPRO SORB F Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration
Study Start Date : June 2007
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : May 2009

Intervention Details:
    Device: HYPRO SORB F
    resorbable, double layered, collagen membrane


Primary Outcome Measures :
  1. expected [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: watad sami, CARDIOPHIL LTD
ClinicalTrials.gov Identifier: NCT00454038     History of Changes
Other Study ID Numbers: ae-01.CTIL
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: January 2009

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

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