Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

NCT04902456 | Unknown

• 1 other identifier: FUE.REC (13)/7-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction. The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

Conditions

Bimaxillary Protrusion

Keywords

En-masse Retraction; Friction; Frictionless; CBCT; Anchorage; Anchorage loss; Dental models

Outcome Measures

Primary Outcomes (1)

• Anchorage loss

  Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )

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

Secondary Outcomes (6)

• Retraction Rate

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

• Molar Rotation

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

• Pain of Intervention

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

• Anterior teeth extrusion/intrusion

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

• Anterior teeth torque

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

Study Arms (2)

Power Chain and Crimpable hook for En-masse retraction

EXPERIMENTAL

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

Procedure: Power chain and Crimpable hook fro En-masse Retraction

T-loop

EXPERIMENTAL

Closing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine.

Procedure: T-loop

Interventions

Power chain and Crimpable hook fro En-masse Retraction PROCEDURE

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

Power Chain and Crimpable hook for En-masse retraction

T-loop PROCEDURE

closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.

T-loop

Eligibility Criteria

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

You may qualify if:

• Orthodontic patients (both genders)
• Age range (14-24)
• Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
• Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
• Cases requiring maximum anchorage during anterior segment retraction.
• Cases with minimal crowding (2-3) mm

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)

Amr Attia

Cairo, Future University in Egypt, 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 15, 2021
• First Posted: May 26, 2021
• Study Start: December 29, 2020
• Primary Completion: January 29, 2022
• Study Completion: January 29, 2022
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

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

Locations

EG (1)