3D Radiographic Evaluation of a Novel Implant Site Development Technique

Sponsor
Semmelweis University (Other)
Overall Status
Completed
CT.gov ID
NCT02660697
Collaborator
(none)
43
1
2
84
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extraction site development
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
3D Radiographic Evaluation of Post-extraction Healing Following Treatment With a Novel Implant Site Development Technique
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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).
Other Names:
  • XSD
  • No Intervention: 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Semmelweis University Department of Periodontology Budapest Hungary 1088

    Sponsors and Collaborators

    • Semmelweis University

    Investigators

    • Principal Investigator: Balint Molnar, DMD, PhD, Semmelweis University Department of Periodontology

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Balint Molnar, Dr. Balint Molnar DMD, PhD, assistant professor, Semmelweis University
    ClinicalTrials.gov Identifier:
    NCT02660697
    Other Study ID Numbers:
    • XSD-Semmelweis-Perio
    First Posted:
    Jan 21, 2016
    Last Update Posted:
    Jan 26, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Balint Molnar, Dr. Balint Molnar DMD, PhD, assistant professor, Semmelweis University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2016