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3D Radiographic Evaluation of a Novel Implant Site Development Technique

Primary Purpose

Tooth Extraction Status Nos, Edentulous Alveolar Ridge

Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Extraction site development
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction Status Nos focused on measuring socket preservation, implant site development

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Semmelweis University Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Test - Extraction site development group

Control - Spontaneous healing group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Minimal orovestibular socket dimension feasible for implant placement
Minimal orovestibular socket dimension feasible for implant placement was defined as 6mm
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
Socket area
On prealigned pre- and postoperative CBCT cross-sections, planimetric measurements were taken to determine the cross-section area of extractions sites

Full Information

First Posted
January 18, 2016
Last Updated
January 22, 2016
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT02660697
Brief Title
3D Radiographic Evaluation of a Novel Implant Site Development Technique
Official Title
3D Radiographic Evaluation of Post-extraction Healing Following Treatment With a Novel Implant Site Development Technique
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Extraction Status Nos, Edentulous Alveolar Ridge
Keywords
socket preservation, implant site development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test - Extraction site development group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control - Spontaneous healing group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Extraction site development
Other Intervention Name(s)
XSD
Intervention Description
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).
Primary Outcome Measure Information:
Title
Orovestibular socket dimension
Description
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
Time Frame
From baseline to 6-9 months postoperatively
Secondary Outcome Measure Information:
Title
Minimal orovestibular socket dimension feasible for implant placement
Description
Minimal orovestibular socket dimension feasible for implant placement was defined as 6mm
Time Frame
From baseline to 6-9 months postoperatively
Title
Vertical socket dimension
Description
On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken perpendicularly to a reference base to determine the height of extractions sites
Time Frame
From baseline to 6-9 months postoperatively
Title
Socket area
Description
On prealigned pre- and postoperative CBCT cross-sections, planimetric measurements were taken to determine the cross-section area of extractions sites
Time Frame
From baseline to 6-9 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balint Molnar, DMD, PhD
Organizational Affiliation
Semmelweis University Department of Periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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3D Radiographic Evaluation of a Novel Implant Site Development Technique

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