3D Radiographic Evaluation of a Novel Implant Site Development Technique

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660697
• Other study ID #: XSD-Semmelweis-Perio
• 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

• Edentulous Alveolar Ridge
• Tooth Extraction Status Nos

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

External Links

•   Ethics committee homepage
•   Institutional homepage