Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration

August 30, 2018 updated by: Dr. France LAMBERT, University of Liege

Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration : a Prospective Study

This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.

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.

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.
10

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

  • Belgium
      • Liège, Belgium, 4000
        • CHU University of Liège

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients requiring at least mandible orthodontic treatment (both arches)
  • Patient presenting alveolar bone thickness < XX mm
  • Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
  • Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
  • American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
  • Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries).

Exclusion criteria were as follows:

  • Controlled periodontitis with a loss of alveolar support > 10%
  • Gingival recession > 2 mm
  • Smokers
  • Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
  • Mental or motor disabilities
  • Pregnancy

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Radiographic change from Baseline and after 1year
Time Frame: Baseline and after 1year
The patients underwent baseline and post treatment CBCT scans (Somaton® Emotion; Siemens, Munich, Germany). Measurements of the alveolar bone changes in the lower front region on pre- and post- treatment CT volumes were done by reformatting the orthogonal slices, along the sagittal, coronal and axial length axes of each individual tooth. A strict vestibular bone level measurement (sagittal slice) and three alveolar bone width measurements at crestal level, 3mm from the crest and 6mm from the crest (axial slices) were performed per individual tooth. In addition, CT images were analyzed in using a dedicated platform in an image processing software (MeVisLab, MeVis Medical Solutions AG, Bremen,Germany) where pre- and post-treatment volumes were superposed using rigid image registration. Semi-automatically segmentation using region growing with same seed-point and threshold value for both scans, was followed with a hole-filling algorithm to obtain segmented volumes of the cropped image in
Baseline and after 1year

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
Periodontal Evaluation
Time Frame: Baseline and after 1 year
The following clinical parameters were measured at baseline and after the orthodontic treatments: recession depths (RDs), pocket depth, plaque index (PI) and papilla bleeding index (PBI). A recession score was calculated by summing the recession depths. Next, the presence of gingival scars due to the overall treatment of each patient was categorized as an absence of scars, point-shape scars or linear-shape scars. Full periodontal charting (probing in four sites per tooth) was performed in all patients before and after the treatment; the results were expressed as score per sextant.
Baseline and after 1 year
Patient assessment
Time Frame: Baseline and after 1year
The patient-centered outcomes were recorded using a Visual Analog Scale questionnaire that employed a 0-10 graduated scale. The following parameters were collected: apprehension before treatment (scale ranges, minimum=0 and maximum=10) scores), pain level after treatment and daily analgesic consumption following orthodontic appliance placement and piezocision (scale ranges, minimum=0 and maximum=10). After the overall treatment, the levels of satisfaction in terms of the final result (scale ranges, minimum=0 and maximum=10), the treatment duration and whether the patient would recommend the procedure to a friend were assessed (scale ranges, Yes=0 and No=10). Finally, the patients were asked whether they would undergo the treatment again (scale ranges, Yes=0 and No=10).
Baseline and after 1year

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.
University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
March 20, 2017

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.
March 20, 2018

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.
March 20, 2018

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).
June 11, 2018

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.
August 30, 2018

First Posted (Actual)

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.
August 31, 2018

Study Record Updates

Last Update Posted (Actual)

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.
August 31, 2018

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.
August 30, 2018

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.
August 1, 2018

More Information

Terms related to this study

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.
  • P2016-1 In-OP WP2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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