Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

NCT02753153 | Completed Phase 4

• 1 other identifier: H2010-1
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Soft tissue contours measurements by 3D image analyses.

  6months

Other Outcomes (3)

• 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

Study Arms (2)

Mucograft®, Geistlich Biomaterials

EXPERIMENTAL

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; Procedure: Socket preservation

Soft tissue graft

ACTIVE COMPARATOR

Procedure: Control surgical protocol; Procedure: Socket preservation

Interventions

Control surgical protocol 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).

Soft tissue graft

Test surgical protocol 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.

Mucograft®, Geistlich Biomaterials

Socket preservation 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.

Mucograft®, Geistlich Biomaterials; Soft tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. France LAMBERT

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 27, 2016
• Study Start: May 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share