Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics

May 13, 2021 updated by: Monica Guirguis Youssif Tawfik, Future University in Egypt

Evaluation of the Rate of Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

  • Egypt
      • Cairo, Egypt
        • Future Univeristy in Egypt

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

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Subjects.
  • Age 13-25 y of age.
  • Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
  • Fully erupted permanent dentition without crowding.
  • Good oral and general health.

Exclusion Criteria:

  • Systemic Diseases or syndromes or on anti-inflammatory medication.
  • Extracted or missing permanent teeth.
  • History of previous Orthodontic Treatment.
  • Parafunctional Habits.
  • Badly decayed teeth.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anterior Segment Retraction using Friction mechanics by elastomeric power chains
Elastomeric power chains extending from 8mm crimpable hooks, distal to the lateral incisors, on 0.017"x0.025" Stainless Steel WIres, to the mini-screws. The power chains delivered 160g of force per side.
Other: Friction Mechanics
anterior segment retraction using elastomeric power chains
Other Names:
  • sliding mechanics
Experimental: Anterior Segment Retraction using Frictionless mechanics by T-loops
T shaped closing loops were fabricated on 0.017"x0.025" Titanium- Molybdenum wires (TMA) were used to deliver 160g of force per side by 4mm distal activations.
Other: Frictionless Mechanics
anterior segment retraction using closing loops
Other Names:
  • segmented mechanics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Anterior Segment Retraction
Time Frame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
The rate of anterior segment retraction per month was measured on monthly digital models.
The start of anterior segment retraction up to complete space closure, an average of 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anchorage Loss
Time Frame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Mesial movement of the first primary molar was evaluated on the digital models
The start of anterior segment retraction up to complete space closure, an average of 6 months.
Pain experienced after each activation of the two mechanics
Time Frame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Patients were asked to complete Visual Analogue Scales of the degree of pain after every intervention. The scale values between 0 to 10, with 0 being no pain experienced by the patient and 10 being the highest level of pain experienced.
The start of anterior segment retraction up to complete space closure, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Chair: Yehia Mostafa, Chairman, Future Univeristy in Egypt

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)

February 1, 2019

Primary Completion (Actual)

June 10, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUE.REC 9/10-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD shared.

IPD Sharing Time Frame

After Publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

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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