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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02660697
Other study ID # XSD-Semmelweis-Perio
Secondary ID
Status Completed
Phase Phase 4
First received January 18, 2016
Last updated January 22, 2016
Start date December 2007
Est. completion date December 2014

Study information

Verified date January 2016
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority Hungary: Institutional Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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).

Locations

Country Name City State
Hungary Semmelweis University Department of Periodontology Budapest

Sponsors (1)

Lead Sponsor Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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