Guided Bone Regeneration Using Synthetic Membrane

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by RegeneCure, Ltd.
Sponsor:
Information provided by (Responsible Party):
RegeneCure, Ltd.
ClinicalTrials.gov Identifier:
NCT01654627
First received: July 26, 2012
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01654627

Contacts
Contact: Michal Limor, MD + 972-2-5401013 michal@regenecure.co.il

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

No publications provided

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

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

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014