Guided Bone Regeneration Using Synthetic Membrane

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01654627
• Other study ID #: RGD001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 26, 2012
• Last updated: August 26, 2013
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: RegeneCure, Ltd.
• Contact: Michal Limor, MD
• Phone: + 972-2-5401013
• Email: michal[@]regenecure.co.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Intervention

Device:
• Regenecure AMCA GBR Dental Membrane
Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane
• Geistlich Bio-Gide® collagen membrane
The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.

Locations

Country	Name	City	State
Israel	Department of Periodontology Hadassah and Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
RegeneCure, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume	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.	Change from Baseline in bone volume at 6 months	No
Secondary	Histomorphometry	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.	6 months	No
Secondary	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	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	six months	Yes