Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

Study Overview
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Brief Summary
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This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas: 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses ) Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )

Official Title
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Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial

Conditions
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Tooth Lost

Intervention / Treatment
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* Procedure: Control surgical protocol
* Procedure: Test surgical protocol
* Procedure: Socket preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar) Good general health (ASA 1, 2) Controlled periodontitis No age restriction Exclusion Criteria: Extraction socket with buccal bone defect / buccal bone wall dehiscence Smokers > 10 cigarettes per day Immune system disease Bone disease or treatment by medicines interfering with bone metabolism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucograft®, Geistlich Biomaterials<br>A Mucograft membrane will be used in state of a connective tissue graft. The dimension of the Mucograft® will be previously calculated according to the site dimensions and inserted into buccal pouch and sutured to be stabilized on the buccal aspect. The membrane is then positioned to cover the socket and inserted and sutured in the palatal pouch by the means of vertical interrupted sutures | Procedure: Test surgical protocol<br>* The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.<br>Procedure: Socket preservation<br>* An atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues. Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied.<br>|
| Active Comparator: Soft tissue graft<br> | Procedure: Control surgical protocol<br>* A connective tissue graft will be harvested to the palate or posterior maxilla tuberosity. The dimension of the graft will be previously calculated according to the socket dimensions. The harvesting site will be made with a single edge incision and sutured with 4.0 silk (uninterrupted suture). The connective tissue graft will be reshaped if necessary to be 1-2mm thick and inserted into buccal pouch and sutured with 2 vertical interrupted sutures to be stabilized on the buccal aspect. The connective tissue graft is then positioned to caver the socket and inserted and sutured in the palatal pouch also by the means of vertical interrupted sutures (polypropylen 6.0).<br>Procedure: Socket preservation<br>* An atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues. Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone remodeling of the buccal and palatal walls using radiographic measurements | Bone remodeling of the buccal and palatal walls will be measured in cone beam computerized tomography (CBCT) on the day of extraction, at 3 months after implant placement. | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue contours measurements by 3D image analyses. | Models from the different time points are scanned using 3D-Laser-Scanner and Software (Metalor). 3D reconstructions are matched in order to evaluate 3D and 2D volume changes in extraction sites from baseline to implant placement. | 6months |