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

NCT ID: NCT04892056

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bimaxillary Protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Blinding of the principal investigator was not possible due to the nature of the interventions. However, the outcome assessor was blinded to the interventions and all digital models were unidentified during outcome assessment.

Study Groups

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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.

Group Type EXPERIMENTAL

Friction Mechanics

Intervention Type OTHER

anterior segment retraction using elastomeric power chains

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.

Group Type EXPERIMENTAL

Frictionless Mechanics

Intervention Type OTHER

anterior segment retraction using closing loops

Interventions

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Friction Mechanics

anterior segment retraction using elastomeric power chains

Intervention Type OTHER

Frictionless Mechanics

anterior segment retraction using closing loops

Intervention Type OTHER

Other Intervention Names

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sliding mechanics segmented mechanics

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Monica Guirguis Youssif Tawfik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehia Mostafa, Chairman

Role: STUDY_CHAIR

Future Univeristy in Egypt

Locations

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Future Univeristy in Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FUE.REC 9/10-2018

Identifier Type: -

Identifier Source: org_study_id

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