The Open Wound Bone Augmentation Concept With Amnion-Chorion Membrane

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.

Detailed Description
-----------------
Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal. Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals. 20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.

Official Title
-----------------
The Open Wound Bone Augmentation Concept With Amnion-Chorion Membrane: A Randomized Controlled Trial

Conditions
-----------------
Horizontal Ridge Deficiency

Intervention / Treatment
-----------------
* Procedure: Guided bone regeneration (GBR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 21 years of age Be missing 1 to 2 back teeth in the lower jaw for at least three months Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically Have enough bone height at the site Exclusion Criteria: Currently smoke more than 10 cigarettes a day (self-reported) Have any medical conditions or jaw pathology that we decide might influence the outcome of the study Are pregnant or are lactating (self-reported) Have unstable periodontal disease or other dental infection Have poor oral hygiene Have any clinical conditions that make the subject unsuitable for bone graft surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Wound<br>After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta and will be left partially open to heal. | Procedure: Guided bone regeneration (GBR)<br>* Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures.<br>* Other names: Horizontal bone augmentation (HBA);|
| Active Comparator: Closed Wound<br>After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with collagen tissue and stitched closed while it heals. | Procedure: Guided bone regeneration (GBR)<br>* Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures.<br>* Other names: Horizontal bone augmentation (HBA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge width changes | Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements | 6 months |