3D Radiographic Evaluation of a Novel Implant Site Development Technique

Study Overview
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Brief Summary
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The present retrospective study aims at assessing the clinical effects of a novel implant site development (Extraction site development - XSD) technique after tooth extraction compared with extraction alone in patients requiring dental implant placement following healing of extraction sockets.

Detailed Description
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In advanced (Extraction Defect Sounding Class 3-4) alveolar defects, a minimally invasive tunnelised socket preservation technique utilising long term resorbable membranes and connective tissue grafting was used for extraction site development (XSD). The novel technique was evaluated in a retrospective comparative case series study including a total of 54 extraction sites. In the test group, out of 33 single rooted teeth, 29 in the maxilla and 4 in the mandible were removed, extractions sites were treated by the XSD method. Out of 33 teeth, 27 were incisors, 2 canines and 4 premolars. In the control group, out of 21 single rooted teeth, 11 in the maxilla and 10 in the mandible were extracted and left for spontaneous healing. Out of 21 teeth, 13 were incisors, 2 canines and 6 premolars. CBCT scans were taken prior to tooth extraction and 6-9 months later in both groups. Radiographic evaluation was carried out using the I-CAT Vision (Imaging Sciences International, LLC; Hatfield, USA) and ImageJ (National Institutes of Health) softwares. Following manual alignment of CBCTs vertical and horizontal linear measurements as well as planimetric measurements of cross-section areas were performed in pre- and postoperative data sets at the extraction sites.

Official Title
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3D Radiographic Evaluation of Post-extraction Healing Following Treatment With a Novel Implant Site Development Technique

Conditions
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Tooth Extraction Status Nos, Edentulous Alveolar Ridge

Intervention / Treatment
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* Procedure: Extraction site development


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least 1 single rooted tooth scheduled for extraction with EDS Class 3-4 type buccal bony dehiscence Exclusion Criteria: Exclusion criteria int he test group included uncontrolled inflammation at the surgical site, full mouth plaque or bleeding scores more than 20%, diabetes, pregnancy, known metabolic bone diseases, smoking more than 10 cigarettes a day, history of any relevant systemic diseases, radiotherapy chronic use of bisphosphonates or systemic steroids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test - Extraction site development group<br>In the test group 29 healthy patients presenting 33 single rooted teeth scheduled for extraction with Extraction Defect Sounding (EDS) Class 3-4 type buccal bony dehiscences were included. 29 maxillary single rooted teeth and 4 single rooted teeth in the mandible (27 incisors, 2 canines and 4 premolars) were removed and treated by the novel extraction site development method. Pre- and postoperative ConeBeam Computer Tomography (CBCT) data were collected for further analysis. | Procedure: Extraction site development<br>* In the test group, extraction sockets presenting EDS Type 3-4 buccal bony dehiscences were treated by a novel minimally invasive tunnelised modified GBR approach (XSD).<br>* Other names: XSD;|
| No Intervention: Control - Spontaneous healing group<br>In the control group. pre- and postextraction CBCT data sets of 14 patients with 21 extracted teeth were collected. 11 maxillary single rooted teeth and 10 single rooted teeth in the mandible (13 incisors, 2 canines and 6 premolars) were extracted and left for spontaneous healing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orovestibular socket dimension | On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of extractions sites | From baseline to 6-9 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal orovestibular socket dimension feasible for implant placement | Minimal orovestibular socket dimension feasible for implant placement was defined as 6mm | From baseline to 6-9 months postoperatively | 
| Vertical socket dimension | On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken perpendicularly to a reference base to determine the height of extractions sites | From baseline to 6-9 months postoperatively | 
| Socket area | On prealigned pre- and postoperative CBCT cross-sections, planimetric measurements were taken to determine the cross-section area of extractions sites | From baseline to 6-9 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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socket preservation, implant site development