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Guided Bone Regeneration Using Synthetic Membrane

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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
Sponsor:
Information provided by (Responsible Party):
RegeneCure, Ltd.

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: RegeneCure, Ltd.
ClinicalTrials.gov Identifier: NCT01654627     History of Changes
Other Study ID Numbers: RGD001
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 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