Clinical Trial: Guided Bone Regeneration Using Synthetic Membrane

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.

Brief Summary: The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.

Detailed Summary:
Sponsor: RegeneCure, Ltd.

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

Information By: RegeneCure, Ltd.

Dates:
Date Received: July 26, 2012
Date Started: April 2013
Date Completion: June 2015
Last Updated: August 26, 2013
Last Verified: August 2013