The Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design (RCT)

February 12, 2021 updated by: Hadeel alaathal, Jordan University of Science and Technology

Three Dimensional Analysis of the Rate of Space Closure With Piezocision-based Corticotomy in Different Facial Types: A Split-mouth Design Randomized Controlled Trial

23 female participants with class II div I will have extraction of bilateral first bicuspids 10 weeks after bond- up appointment. The extracted teeth will be preserved in special containers for subsequent microscopic analysis. Four months later, upon space closure phase, the patient will have a piezocision surgery on one side randomly chosen. Virtual models will be generated once before the surgery and monthly after for four and a half months. The models will be scanned by CADCAM and later tooth movement will be analyzed in regards to the rugae area.

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.
23

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

  • Jordan
      • Irbid, Jordan, 21110
        • Postgraduate orthodontic clinics, Jordan University of Science and Technology

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 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Young adults and adults (15-29).
  • Middleastern Caucasian.
  • Females.
  • Having the defined orthodontic appliance, slot size, prescription, and technique of space closure.
  • Class II division I of moderate space requirement that is planned to have the first premolar extracted.
  • Average or high facial type.
  • Healthy patients without systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) to avoid oral surgery.
  • No active periodontal diseases as this effect the cytokines expression (stabilized prostaglandin (PG) health)
  • Good oral hygiene.
  • No other method of non-surgical acceleration technique to be used.

Exclusion Criteria:

  • Patients who refused to consent for the study.
  • The two extremes of age (younger than 14 and older than 29).
  • Having other than the defined orthodontic appliance, slot size, prescription, and technique of space closure.
  • Extraction cases of high space requirements or other teeth than the first premolar.
  • Patients with systematic diseases that could affect bone and tooth movement and no contraindication (medical or psychological) avoid oral surgery.
  • Active periodontal diseases.
  • Other methods of non-surgical acceleration technique to be used.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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: Piezocision on high facial divergence
Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure.
Procedure: Piezocision Surgery
After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
No Intervention: High facial divergence
Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure.
Experimental: Piezocision on average facial divergence
Piezocision Surgery prior to space closure with closing coil spring four months after extraction. Six weeks later, three follow up appointments, six weeks apart, taking impressions to measure the rate of space closure.
Procedure: Piezocision Surgery
After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
No Intervention: Average facial divergence
Space closure with coil spring four months after extraction. Six weeks later, three other follow up appointments, six weeks apart, taking impressions to measure the rate of space closure.

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 space closure
Time Frame: four and half months
Every six weeks from the first impression, made on the day of surgery (T0), an impression will be taken, (T1, T2, T3). Images of the impressions will be generated using computer-aided design and computer-aided manufacturing (CADCAM) to evaluate the space changes from a fixed reference point; the rugae area.
four and half months

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
Time Frame: Ten weeks

The extraction will take place 10 weeks after the bonding up-appointment. Atraumatic extraction of the upper first premolars will be executed. The periodontist, performing the extraction, will have the extracted teeth stored in containers that contain sterilized deionized water.

Each tooth will be placed in ultrasonic bath for 10 minutes to loosen any residual periodontal ligament's and soft tissue fragments' traces which will be later removed by wet gauze with a rubbing motion. Each tooth will be scanned three dimensionally by a desktop X-ray micro-tomography system. Teeth will be scanned with X-rays while being rotated over 360°. Three-dimension object will be generated by a 3D cone beam reconstruction algorithm utilizing the 2D images that have resulted from the scanning process.
Ten weeks

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.
Jordan University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Edinburgh
University of Sydney

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.
  • Study Director: Kazem S. Alnimri, Professor, Jordan University of Science and Technology

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.
November 1, 2018

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.
November 30, 2020

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 30, 2020

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).
December 14, 2019

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.
December 14, 2019

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.
December 17, 2019

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.
February 16, 2021

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.
February 12, 2021

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.
February 1, 2021

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.
  • 20190232

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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Drug Interventions

Conditions

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