Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.

Detailed Description
-----------------
Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.

Official Title
-----------------
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.

Conditions
-----------------
Clinical Efficacy

Intervention / Treatment
-----------------
* Procedure: One layer allograft
* Procedure: Two layer allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were; one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant at least 18 years of age must sign the informed consent - Exclusion Criteria: The exclusion criteria included: uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium previous head and neck radiation oral bisphosphonates for > 3 years or any IV bisphosphonates smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing requirement for prophylactic antibiotics allergies to any medication or material used in the study, or that would adversely affect study procedures chemotherapy in the previous 12 months psychological problems that would interfere with treatment patients unable or unwilling to sign the informed consent pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one layer allograft<br>One layer allograft as a positive control | Procedure: One layer allograft<br>* The acellular dermal matrix was placed on the facial surface.<br>* Other names: One layer of acellular dermal matrix (Alloderm).;|
| Experimental: Two layer allograft<br>Two layer allograft as the test group. | Procedure: Two layer allograft<br>* The acellular dermal matrix was placed on the facial surface.<br>* Other names: Two layers of acellular dermal matrix (Alloderm).;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue thickness. | Determining the soft tissue thickness using a tissue probe. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allograft, acellular dermal matrix, Alloderm