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Guided Bone Regeneration Using Synthetic Membrane

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by RegeneCure, Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
RegeneCure, Ltd. Identifier:
First received: July 26, 2012
Last updated: August 26, 2013
Last verified: August 2013
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.

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.

Further study details as provided by RegeneCure, Ltd.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must have voluntarily signed the informed consent form before any study related action
  • Age: 18 to 65 with missing teeth, seeking for implant therapy.
  • Men/Women
  • In good systemic health
  • Present with no contra indication against oral surgical interventions
  • Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
  • The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
  • Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
  • Full mouth plaque score (FMPI) lower or equal than 25%
  • Patients must be committed to the study

Exclusion Criteria:

  • Medical conditions requiring prolonged use of steroids
  • Use of Bisphosphonate intravenously
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Immunocompromised patients
  • Uncontrolled Diabetes
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
  • Untreated inflammation
  • Mucosal diseases or oral lesions
  • History of local irradiation therapy
  • Persistent intraoral infection
  • Patients with bad oral hygiene or unmotivated for normal home care.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01654627

Contact: Michal Limor, MD + 972-2-5401013

Department of Periodontology Hadassah and Hebrew University Medical Center Recruiting
Jerusalem, Israel
Sponsors and Collaborators
RegeneCure, Ltd.
Principal Investigator: Lior Shapira, PhD Haddasah Medical Center, Jerusalem Israel
  More Information

Responsible Party: RegeneCure, Ltd. Identifier: NCT01654627     History of Changes
Other Study ID Numbers: RGD001
Study First Received: July 26, 2012
Last Updated: August 26, 2013

Keywords provided by RegeneCure, Ltd.:
Guided Tissue Regeneration
Dental Implants
Membrane, Synthetic

Additional relevant MeSH terms:
Mouth, Edentulous
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases processed this record on May 25, 2017