Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

NCT ID: NCT04902430

Last Updated: 2022-12-07

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

2020-12-29

Study Completion Date

2022-08-12

Brief Summary

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There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless Mechanics.

Detailed Description

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The en-masse technique can be done in one of two ways: through friction or frictionless mechanics. Both are viable options, but, ideally, we want to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these mechanics results in a decreased treatment time is still up for debate.

Conditions

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Bimaxillary Protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

Study Groups

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En-Masse Retraction using sliding mechanics (Friction)

6 anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain

Group Type EXPERIMENTAL

Power chain and Crimpable hook for En-Masse Retraction

Intervention Type PROCEDURE

Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew

En-Masse Retraction using segmental mechanics (Frictionless)

6 anterior teeth (en-Masse) retracted using a T- loop

Group Type EXPERIMENTAL

T- Loop

Intervention Type PROCEDURE

Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine

Interventions

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Power chain and Crimpable hook for En-Masse Retraction

Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew

Intervention Type PROCEDURE

T- Loop

Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults and Adolescent patients (both genders)
* Age range (14-24)
* Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
* Patients with fully erupted permanent teeth (not necessarily including the third molar).
* Cases requiring maximum anchorage during retraction.
* Good general and oral health

Exclusion Criteria

* Patients suffering from any systemic diseases interfering with tooth movement.
* Patients with extracted or missing permanent teeth. (except for third molars).
* Patients with badly decayed teeth.
* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
* Patients with previous orthodontic treatment
Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Leena Alaa Shibl

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehia Mostafa, Professor and Chairman

Role: STUDY_DIRECTOR

Future University in Egypt

Locations

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Future University in Egypt

New Cairo, Cairo Governorate, 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 (8)/6-2019

Identifier Type: -

Identifier Source: org_study_id

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