3D Radiographic Evaluation of a Novel Implant Site Development Technique

Phase 4

Completed

• Conditions: Edentulous Alveolar Ridge; Tooth Extraction Status Nos
• Interventions: Procedure: Extraction site development

• Registration Number: NCT02660697
• Lead Sponsor: Semmelweis University

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-18
• Study First Posted: 2016-01-21
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test - Extraction site development group	Extraction site development	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.

Primary Outcome Measures

Name	Time	Method
Orovestibular socket dimension	From baseline to 6-9 months postoperatively	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary