3D Radiographic Evaluation of a Novel Implant Site Development Technique

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Tooth Extraction Status Nos Edentulous Alveolar Ridge

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test - Extraction site development group

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.

Group Type ACTIVE_COMPARATOR

Extraction site development

Intervention Type PROCEDURE

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).

Control - Spontaneous healing group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extraction site development

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).

Intervention Type PROCEDURE