Evaluation of Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction

NCT05150665 | Unknown

• 1 other identifier: FUE.REC(26)/12-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There's a scarcity in literature concerning mini-esthetics specially maxillary gingival display changes following en-masse retraction and two-step retraction. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which technique of retraction will result in better esthetics upon smiling following en-masse retraction or two step retraction mechanics.

Conditions

Bimaxillary Protrusion

Keywords

Mini-esthetics; Macro-esthetics; En-masse Retraction; Two step retraction; Extra-oral photographs; Adobe photoshop CC 2017 software; Lateral Cephalometric Radiographs

Outcome Measures

Primary Outcomes (1)

• Mini-esthetics including

  Evaluation of (maxillary gingival display, Smile arc, buccal corridor) from social smile photograph Evaluation of (inter-labial gap) from At Rest photograph All primary outcome characteristics will be measured before and after retraction (measured Linear/ horizontal/ vertical in millimeters) by Adobe Photoshop CC 2017 software.

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

Secondary Outcomes (1)

• Macro-esthetics evaluation of profile photograph including

  upto 6 months from the start of orthodontic treatment.

Study Arms (2)

En-Masse Retraction

EXPERIMENTAL

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

Procedure: En-masse retraction

two step retraction

EXPERIMENTAL

Six anterior teeth are retracted by two step technique by canine retraction followed by four anterior teeth retraction using a crimpable hook distal to the upper lateral incisor and a power chain

Procedure: Two step Retraction

Interventions

En-masse retraction 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 200 g per side) extending between the crimpable hooks and the miniscrew

En-Masse Retraction

Two step Retraction PROCEDURE

Retraction of canine started on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 150 g per side)followed by anterior teeth retraction on 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 160 g per side) extending between the crimpable hooks and the mini-screw.

two step retraction

Eligibility Criteria

• Age: 16 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 (16-24)
• 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 neural disorders or systemic diseases interfering with tooth movement.
• Patients with soft tissue problems such as cleft-palate patients
• 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

Cairo, Egypt

Location

Study Officials

• Yehya 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 photographs and cephalometric radiographs. 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: November 26, 2021
• First Posted: December 9, 2021
• Study Start: October 29, 2020
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

EG (1)