Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

Phase 4

Completed

• Conditions: Tooth Lost
• Interventions: Procedure: Test surgical protocol; Procedure: Control surgical protocol; Procedure: Socket preservation

• Registration Number: NCT02753153
• Lead Sponsor: University of Liege

Brief Summary

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 )

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-22
• Last Update Submitted: 2016-04-22
• Study First Posted: 2016-04-27
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucograft®, Geistlich Biomaterials	Socket preservation	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
Mucograft®, Geistlich Biomaterials	Test surgical protocol	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
Soft tissue graft	Socket preservation	-
Soft tissue graft	Control surgical protocol	-

Primary Outcome Measures

Name	Time	Method
Bone remodeling of the buccal and palatal walls using radiographic measurements	1year	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.

Secondary Outcome Measures

Name	Time	Method
Soft tissue contours measurements by 3D image analyses.	6months	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.