Effects on Maxillary Anterior Dentition Following En Masse Retraction Using Mini-implants and Various Heights of Anterior Power Arm.

October 22, 2022 updated by: Tahira Arif, Dow University of Health Sciences

Effects On Maxillary Anterior Dentition Following En- Masse Retraction Using Mini-Implants and Various Heights of Anterior Power Arm- A Randomized Controlled Trial

The controlled three dimensional movement of anterior dentition during orthodontic treatment is a desire of every orthodontist. Maxillary en masse retraction with mini implants has been reported to provide absolute anchorage thus utilizing the complete extraction spaces thereby enhancing patient's esthetics. Power arm or anterior retraction hook permits the application of force close to a desired direction thereby warranting better anterior dentition control. Various heights of power arms and proposed centre of resistance for six maxillary anterior teeth have been estimated through finite element model and also from a very limited number of clinical studies. For a set of teeth, the determination of centre of resistance is complex in actual clinical scenario and response of force applied from certain level for better anterior dentition control requires sufficient clinical evidence suggestive of further clinical studies to endow orthodontists to hasten treatment due to less time consumption during finishing stage of orthodontic treatment.

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

This Randomized Control Trial will be conducted to compare the effects of various heights of anterior power arm on maxillary anterior dentition following en masse retraction with mini-implants by participation of thirty patients meeting eligibility criteria. The participants will be divided in three groups through software generated randomization table. Group I (control group; height of anterior power arm 6 mm), Group II and Group III (experimental groups; height of anterior power arm 3 mm and 9 mm, respectively). Ten patients will be allocated in each group. En masse retraction with mini implants and various heights of anterior power arm will be carried out immediately after bilateral maxillary first premolar extractions using continuous arch sliding mechanics. Horizontal, vertical and angular dimensions will be measured on lateral cephalograms while the transverse effects will be measured on maxillary dental cast. Both lateral cephalograms and dental casts will be obtained at two different point of time; T1, before retraction and T2, after complete extraction space closure. The data will be assessed with-in and among groups.

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Department of Orthodontics , DIEKIOHS, Dow University Of Health Sciences, Ojha Campus.

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Patients between ages 18-30 years.
  • Good oral hygiene and healthy periodontal tissues.
  • Patients having overjet ≥ 7 mm and ≤ 10 mm and overbite of 2-3 mm.
  • Pt with molar relation angle's full cusp Class II requiring symmetric extractions of maxillary 1st premolars and maximum anchorage.
  • Patients having coincident maxillary midline with the facial midline.

Exclusion criteria

  • Patients with maxillary anterior teeth have dilacerations, fusion, hyper-cementosis, shorter roots or any other tooth anomaly.
  • Patients with traumatized or impacted teeth in the anterior maxilla.
  • Patients with moderate to severe crowding in maxillary and mandibular arch.
  • History of bone metabolic disorders or patients receiving drugs that alter bone metabolism.
  • History of systemic diseases or hormonal imbalance that hinders orthodontic tooth movement.

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.
Active Comparator: Group I
6 mm height of power arm
Other: Anterior Power Arm
Crimpable stainless steel hook placed on orthodontic base arch wire.
Other Names:
  • Anterior Retraction Hook
Experimental: Group II
3 mm height of power arm
Other: Anterior Power Arm
Crimpable stainless steel hook placed on orthodontic base arch wire.
Other Names:
  • Anterior Retraction Hook
Experimental: Group III
9 mm height of power arm
Other: Anterior Power Arm
Crimpable stainless steel hook placed on orthodontic base arch wire.
Other Names:
  • Anterior Retraction Hook

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
Change in maxillary central incisor sagittal dimension
Time Frame: Upto 1 year
IoSV (mm), IaSV (mm), IaSV/IoSV
Upto 1 year
Change in maxillary central incisor vertical dimension
Time Frame: Upto 1 year
IoPP (mm), IaPP (mm)
Upto 1 year
Change in maxillary central incisor angular dimension
Time Frame: Upto 1 year
I-angle (degrees)
Upto 1 year
Change in maxillary anterior transverse dimension
Time Frame: Upto 1 year
Intercanine width (mm)
Upto 1 year

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.
Dow University of Health Sciences

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: Tahira Arif, Dow University of Health Sciences

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.
June 25, 2019

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 1, 2021

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 1, 2021

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).
November 24, 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 1, 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 3, 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.
October 25, 2022

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 22, 2022

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, 2022

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.
  • TARIF

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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