Guided Bone Regeneration Using Synthetic Membrane

Phase 1

• Conditions: Jaw, Edentulous; Jaw, Edentulous, Partially
• Interventions: Device: Regenecure AMCA GBR Dental Membrane; Device: Geistlich Bio-Gide® collagen membrane

• Registration Number: NCT01654627
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-29
• Study First Posted: 2012-08-01
• Study Start: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27
• Primary Completion: 2015-04
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenecure AMCA GBR Dental membrane	Regenecure AMCA GBR Dental Membrane	16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane
Collagen membrane	Geistlich Bio-Gide® collagen membrane	16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane

Primary Outcome Measures

Name	Time	Method
Bone volume	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

Name	Time	Method
Histomorphometry	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	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

Trial Locations

Locations (1)

Department of Periodontology Hadassah and Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel