Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation

Study Overview
=================
Brief Summary
-----------------
This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

Detailed Description
-----------------
Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM. 30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.

Official Title
-----------------
Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation

Conditions
-----------------
Healing Wound

Intervention / Treatment
-----------------
* Procedure: Socket preservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 20 to 80 years. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable. Socket should be free of infection, less than 5mm of dehiscence Patients interested in implant placement following tooth extraction. Exclusion Criteria: Allergies or hypersensitivities to study related medications such as chlorhexidine. Hematologic disorders/blood dyscrasias. Active infectious diseases of any kind. Liver or kidney dysfunction/failure. Uncontrolled diabetes (HbA1c > 8). Active cancer treatment - such as active chemotherapy or radiation therapy. Taking medications that will affect their bone healing (for example, bisphosphonates). Metabolic bone diseases that affect bone healing such as osteoporosis. Pregnant or lactating women (self-reported). Smoke 10 or more cigarettes per day (self-reported). Poor oral hygiene.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
No

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: Test<br>Amnion-chorion membrane with collagen plug | Procedure: Socket preservation<br>* After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.<br>|
| Active Comparator: Control<br>Collagen plug | Procedure: Socket preservation<br>* After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical alveolar ridge dimension changes | Clinically measured alveolar ridge dimension changes in mm using calibers | 4 months | 
| Digital alveolar ridge dimension changes | Digitally measured alveolar ridge dimension changes in mm2 using CBCT | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological bone density. | Histomorphometry. | 4 months | 
| Presence of bone turnover proteins. | Immunohistochemistry. | 4 months | 
| Implant survival-Clinical | Clinically assessed by torque test using a torque wrench, measured in N/cm. | 6 months | 
| Implant survival-Radiographic | Radiographically assessed through any signs of radiolucency around the implant. | 6 months | 
| Esthetic restorative outcomes. | Clinical changes in hard tissue based on the PES score | 6 months |