3D Radiographic Evaluation of a Novel Implant Site Development Technique

NCT02660697 | Completed Phase 4

• 1 other identifier: XSD-Semmelweis-Perio
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction Status Nos; Edentulous Alveolar Ridge

Keywords

socket preservation, implant site development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Minimal orovestibular socket dimension feasible for implant placement

  From baseline to 6-9 months postoperatively

• Vertical socket dimension

  From baseline to 6-9 months postoperatively

• Socket area

  From baseline to 6-9 months postoperatively

Study Arms (2)

Test - Extraction site development group

ACTIVE COMPARATOR

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

Control - Spontaneous healing group

NO INTERVENTION

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.

Interventions

Extraction site development 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).

Also known as: XSD

Test - Extraction site development group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least 1 single rooted tooth scheduled for extraction with EDS Class 3-4 type buccal bony dehiscence

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, Budapest, 1088, Hungary

Location

Study Officials

• Balint Molnar, DMD, PhD

  Semmelweis University Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Balint Molnar DMD, PhD, assistant professor

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: December 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 26, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)