Guided Bone Regeneration Using Synthetic Membrane

Study Overview
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Brief Summary
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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.

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

Conditions
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Jaw, Edentulous, Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Regenecure AMCA GBR Dental Membrane
* Device: Geistlich Bio-Gide® collagen membrane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regenecure AMCA GBR Dental membrane<br>16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane | Device: Regenecure AMCA GBR Dental Membrane<br>* Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane<br>|
| Active Comparator: Collagen membrane<br>16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane | Device: Geistlich Bio-Gide® collagen membrane<br>* The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Tissue Regeneration, Dental Implants, Membrane, Synthetic