3D Radiographic Evaluation of a Novel Implant Site Development Technique

January 22, 2016 updated by: Balint Molnar, Semmelweis University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Orovestibular socket dimension
Time Frame: 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
From baseline to 6-9 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minimal orovestibular socket dimension feasible for implant placement
Time Frame: From baseline to 6-9 months postoperatively
Minimal orovestibular socket dimension feasible for implant placement was defined as 6mm
From baseline to 6-9 months postoperatively
Vertical socket dimension
Time Frame: 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
From baseline to 6-9 months postoperatively
Socket area
Time Frame: 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
From baseline to 6-9 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Semmelweis University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Balint Molnar, DMD, PhD, Semmelweis University Department of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XSD-Semmelweis-Perio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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