Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

NCT ID: NCT02753153

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-05-31

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 )

Conditions

Tooth Lost

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Test surgical protocol

Intervention Type: PROCEDURE

The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.

Socket preservation

Intervention Type: PROCEDURE

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.

Soft tissue graft

Group Type: ACTIVE_COMPARATOR

Control surgical protocol

Intervention Type: PROCEDURE

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).

Socket preservation

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Dr. France LAMBERT

Prof. Dr. France LAMBERT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

H2010-1

Identifier Type: -

Identifier Source: org_study_id