Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients

October 28, 2015 updated by: Dr. France LAMBERT
This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.

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.
24

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.
  • Not Applicable

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (completed growth)
  • Maxillary and mandibular overcrowding
  • Patient demand for orthodontic treatment
  • Adequate dento-oral health
  • ASA I and ASA II
  • Compliance with clinic visits every 2 weeks

Exclusion Criteria:

  • A need for tooth extraction
  • A need for orthodontic temporary anchorage devices
  • A history of periodontal disease
  • 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: Treatment
  • Allocation: 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: Control group
Treated with conventional orthodontics
Procedure: Orthodontic procedures (for both groups : Control group and Test group)
Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed.
Experimental: Test group
subjected to piezo-assisted orthodontics
Procedure: Orthodontic procedures (for both groups : Control group and Test group)
Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed.
Procedure: Piezo-assisted orthodontics (only the Test group)
The piezocisionTM surgery was performed one week after orthodontic appliance placement . The patients received local anesthesia in both arches, and vertical interproximal micro-incisions were created below each interdental papilla. In cases of root proximity (i.e., less than 2 mm of interdental bone), this procedure was not applied. These incisions were kept to a minimum (varying from 5 mm to 8 mm). Next, using a vertical piezoelectric device, 5-mm long and 3-mm deep corticotomies were made, and no subsequent sutures were required needed (figure 1). The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intakes for one week. Anti-inflammatories were prohibited to avoid interference with the RAP. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.

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
Overall treatment time measurement (in days)
Time Frame: 3 years
Comparaison of the overall treatment time between the test group (piezocision group) and the control group will be performed. It will be evaluated by measuring the time (in days) between the placement and the debond of the orthodontic appliance. The hypothesis is that piezocision accelerate orthodontic tooth movement.
3 years

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
Root resorption parameters measurements (intrabuccal radiographic in millimeters)
Time Frame: 3 years
A comparaison of orthodontic parameters (root resorption) between the test group and the control group before and after orthodontic treatment will be performed. The root resorption will be measured in intrabuccal radiographic (millimeters) on the day of the placement of this appliance and at the debond.
3 years
Comparaison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
Time Frame: 3 years
3 years
Patient-centered outcomes (VAS questionnaire)
Time Frame: 7 days
Satisfaction post treatment using a VAS questionnaire and analgesic consumption (milligrams of paracetamol) during 7 days after the placement of the orthodontic appliance.
7 days

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.
Dr. France LAMBERT

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

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.
February 1, 2013

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.
February 1, 2013

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.
October 1, 2015

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).
October 21, 2015

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.
October 28, 2015

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.
October 29, 2015

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.
October 29, 2015

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.
October 28, 2015

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.
October 1, 2015

More Information

Terms related to this study

Keywords

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.
  • H2013-3

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.

Clinical Trials on Tooth Overcrowding

Clinical Trials on Orthodontic procedures (for both groups : Control group and Test group)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings