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

NCT04902430 | Completed

• 1 other identifier: FUE.REC (8)/6-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bimaxillary Protrusion

Keywords

En-masse Retraction; Friction; Fricitionless; Lateral Cephalometric; Rate; Dental Models

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anchorage Loss

  From pre to post retraction (an average of 6 - 8 months)

• Molar Rotation

  From pre to post retraction (an average of 6 - 8 months)

• Pain of intervention

  From pre to post retraction/intervention (an average of 6 - 8 months)

• Anterior teeth torque, extrusion/intrusion

  From pre to post retraction (an average of 6 - 8 months)

Study Arms (2)

En-Masse Retraction using sliding mechanics (Friction)

EXPERIMENTAL

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

En-Masse Retraction using segmental mechanics (Frictionless)

EXPERIMENTAL

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

Procedure: T- Loop

Interventions

Power chain and Crimpable hook for En-Masse Retraction 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 sliding mechanics (Friction)

T- Loop 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

En-Masse Retraction using segmental mechanics (Frictionless)

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

New Cairo, Cairo Governorate, Egypt

Location

Study Officials

• Yehia Mostafa, Professor and Chairman

  Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 26, 2021
• Study Start: December 29, 2020
• Primary Completion: July 18, 2022
• Study Completion: August 12, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication

Locations

EG (1)