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
About this trial
This is an interventional treatment trial for Tooth Lost
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
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
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®
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