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Study of Collagen Membrane in Guided Bone Regeneration (GBR)

Primary Purpose

Cystectomy, Segmental Growing of Alveolar Tissue, Sinus Lift

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
HYPRO SORB F
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystectomy focused on measuring cystectomy, augmentation, sinus, amputation, implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Baruch Padeh Medical Center, PoriyaRecruiting

Outcomes

Primary Outcome Measures

expected

Secondary Outcome Measures

Full Information

First Posted
March 28, 2007
Last Updated
July 9, 2009
Sponsor
The Baruch Padeh Medical Center, Poriya
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1. Study Identification

Unique Protocol Identification Number
NCT00454038
Brief Title
Study of Collagen Membrane in Guided Bone Regeneration
Acronym
GBR
Official Title
Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2008 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystectomy, Segmental Growing of Alveolar Tissue, Sinus Lift, Root Amputation and Apicoectomy, Periimplantitis
Keywords
cystectomy, augmentation, sinus, amputation, implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
HYPRO SORB F
Intervention Description
resorbable, double layered, collagen membrane
Primary Outcome Measure Information:
Title
expected
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad K Ailabouni, D.M.D
Phone
(972)46652429
Email
emadniss@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Rabab R Jarjoura, D.M.D
Phone
(972)504358785
Email
rababrj@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alabuni Emad
Organizational Affiliation
The Baruch Padeh Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
The Baruch Padeh Medical Center, Poriya
City
Tiberias
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad K Ailabouni, D.M.D
Phone
(972)46652429
Email
emadniss@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Rabab R Jarjoura, D.M.D
Phone
(972)504358785
Email
rababrj@yahoo.com
First Name & Middle Initial & Last Name & Degree
Eran D Front, D.M.D
First Name & Middle Initial & Last Name & Degree
Zvi A Laster, D.M.D
First Name & Middle Initial & Last Name & Degree
Emad K Ailabouni, D.M.D

12. IPD Sharing Statement

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Study of Collagen Membrane in Guided Bone Regeneration

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