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Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

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ClinicalTrials.gov Identifier: NCT02753153
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. France LAMBERT, University Hospital 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 )

Condition or disease Intervention/treatment Phase
Tooth Lost Procedure: Control surgical protocol Procedure: Test surgical protocol Procedure: Socket preservation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial
Study Start Date : May 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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: 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).


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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Dr. France LAMBERT, Prof. Dr. France LAMBERT, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT02753153     History of Changes
Other Study ID Numbers: H2010-1
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No