Study of Collagen Membrane in Guided Bone Regeneration (GBR)
Recruitment status was Recruiting
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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 |
- 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) |
-
Device: HYPRO SORB F
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 |
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| 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 |
| 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 | |
| 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 May 22, 2013