Guided Bone Regeneration Using Synthetic Membrane
|ClinicalTrials.gov Identifier: NCT01654627|
Recruitment Status : Unknown
Verified August 2013 by RegeneCure, Ltd..
Recruitment status was: Recruiting
First Posted : August 1, 2012
Last Update Posted : August 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous Jaw, Edentulous, Partially||Device: Regenecure AMCA GBR Dental Membrane Device: Geistlich Bio-Gide® collagen membrane||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: Regenecure AMCA GBR Dental membrane
16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane
Device: Regenecure AMCA GBR Dental Membrane
Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane
Active Comparator: Collagen membrane
16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane
Device: Geistlich Bio-Gide® collagen membrane
The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.
- Bone volume [ Time Frame: Change from Baseline in bone volume at 6 months ]Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by "subtraction" of the 2 cone beam CTs using digital measurements.
- Histomorphometry [ Time Frame: 6 months ]Specimens will be prepared for histological staining (H&E and Masson's trichrome stain). The stained samples will be evaluated for new bone, residual bone graft, marrow spaces and vascularity.
- Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant [ Time Frame: six months ]Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654627
|Contact: Michal Limor, MD||+ firstname.lastname@example.org|
|Department of Periodontology Hadassah and Hebrew University Medical Center||Recruiting|
|Principal Investigator:||Lior Shapira, PhD||Haddasah Medical Center, Jerusalem Israel|