Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

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

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 )

Study Overview

• Status: Completed
• Conditions: Tooth Lost
• Intervention / Treatment: Procedure: Test surgical protocol; Procedure: Socket preservation; Procedure: Control surgical protocol

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mucograft®, Geistlich Biomaterials; 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; The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.; Procedure: Socket preservation; 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.
ACTIVE_COMPARATOR: Soft tissue graft	Procedure: Socket preservation; 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.; Procedure: Control surgical protocol; 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Explants will be analyzed by X-ray computed microtomography	1year
Explants will be processed for non-decalcified histology using polymethacrylate (PMMA) resin	1year
Bone formation histomorphometric evaluation using a semiautomatic image analyzer	1year

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (ESTIMATE): April 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: H2010-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO