The Use of Corticotomy for Upper Incisors Retraction

July 27, 2018 updated by: Damascus University

Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial

We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group. Both groups will start orthodontic treatment. Once a 0.019*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. Canines will be retracted in the conventional manner. Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

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 the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .

So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

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.
30

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

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

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

15 years to 27 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
  • Overjet less than 10 mm
  • Normal or increased growth pattern (Diagnosed by Y-axis angle)
  • Mild to moderate crowding (Less than 3 mm)
  • After canines retraction , at least 3 mm space should be available distal the lateral incisors
  • Midline deviation shouldn't be more than 3 mm

Exclusion Criteria:

  • Medically contraindicated patients to oral surgery .
  • Existence of general health issue that affect orthodontic teeth movement
  • Previous orthodontic treatment
  • Mixed dentition
  • Hypodontia (Except third molars)
  • Bad oral hygiene

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: Single

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.
Experimental: Corticotomy-assisted Retraction
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
Procedure: Corticotomy-assisted Retraction
Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
No Intervention: Conventional Retraction
Conventional retraction will be used in this group of patients by sliding mechanisms

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
Rate of retraction
Time Frame: This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
Time required for retraction
Time Frame: This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
The time required from the beginning of incisors' retraction till the the completion of this procedure.
This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.

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
Change in the axial inclination of upper incisors
Time Frame: A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
Anchorage loss
Time Frame: This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae . These measurements are made on plaster study models.
This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
Root resorption
Time Frame: An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
This variable is related to the amount of incisor root resorption after treatment in both groups. This is measured on a panoramic image. The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction. Two radiogrpahs are needed.
An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group

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.
Damascus 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: Ghaith Al Imam, DDS, MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria

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.
August 20, 2016

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.
January 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.
April 15, 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).
May 9, 2017

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.
May 9, 2017

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.
May 11, 2017

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.
July 30, 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.
July 27, 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.
July 1, 2018

More Information

Terms related to this study

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.
  • UDDS-Ortho-02-2017

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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