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

Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Bimaxillary Protrusion
• Intervention / Treatment: Procedure: Power chain and Crimpable hook for En-Masse Retraction; Procedure: T- Loop

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • New Cairo, Cairo, Egypt
      • Future university in egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Experimental: En-Masse Retraction using segmental mechanics (Frictionless); 6 anterior teeth (en-Masse) retracted using a T- loop	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retraction Rate	The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)	From pre to post retraction (an average of 6 - 8 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anchorage Loss	Digitilized dental models taken before and after the completion of retraction will be measured by identifying landmarks and reference lines and planes (measured in mm)	From pre to post retraction (an average of 6 - 8 months)
Molar Rotation	Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)	From pre to post retraction (an average of 6 - 8 months)
Pain of intervention	Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10	From pre to post retraction/intervention (an average of 6 - 8 months)
Anterior teeth torque, extrusion/intrusion	The principle investigator will examine pre and post lateral cephalometric radiographs in relation to lines and reference planes (measurements in degrees and mm)	From pre to post retraction (an average of 6 - 8 months)

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 22, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Dental Models; En-masse Retraction; Friction; Fricitionless; Lateral Cephalometric; Rate
• Other Study ID Numbers: FUE.REC (8)/6-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Data will be available 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