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Completed

NCT Number: NCT02753153

Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

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 )

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Key information

Conditions

Tooth Lost Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Bone remodeling of the buccal and palatal walls using radiographic measurements

    Time frame: 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 outcomes

  1. Soft tissue contours measurements by 3D image analyses.

    Time frame: 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.

Other outcomes

  1. Explants will be analyzed by X-ray computed microtomography

    Time frame: 1year

  2. Explants will be processed for non-decalcified histology using polymethacrylate (PMMA) resin

    Time frame: 1year

  3. Bone formation histomorphometric evaluation using a semiautomatic image analyzer

    Time frame: 1year

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2016
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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