search
Back to results

Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

Primary Purpose

Tooth Lost

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Control surgical protocol
Test surgical protocol
Socket preservation
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Lost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mucograft®, Geistlich Biomaterials

    Soft tissue graft

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 14, 2016
    Last Updated
    April 22, 2016
    Sponsor
    University of Liege
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02753153
    Brief Title
    Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®
    Official Title
    Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 )

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Lost

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mucograft®, Geistlich Biomaterials
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Soft tissue graft
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Control surgical protocol
    Intervention Description
    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
    Intervention Name(s)
    Test surgical protocol
    Intervention Description
    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
    Intervention Name(s)
    Socket preservation
    Intervention Description
    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 Measure Information:
    Title
    Bone remodeling of the buccal and palatal walls using radiographic measurements
    Description
    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.
    Time Frame
    1year
    Secondary Outcome Measure Information:
    Title
    Soft tissue contours measurements by 3D image analyses.
    Description
    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.
    Time Frame
    6months
    Other Pre-specified Outcome Measures:
    Title
    Explants will be analyzed by X-ray computed microtomography
    Time Frame
    1year
    Title
    Explants will be processed for non-decalcified histology using polymethacrylate (PMMA) resin
    Time Frame
    1year
    Title
    Bone formation histomorphometric evaluation using a semiautomatic image analyzer
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

    We'll reach out to this number within 24 hrs