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

Evaluation of Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction in Maxillary Protrusion Cases: A Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bimaxillary Protrusion
• Intervention / Treatment: Procedure: En-masse retraction; Procedure: Two step Retraction

Detailed Description

This study will be conducted in order to evaluate which technique of retraction will provide better outcome regarding mini and macro esthetics. In terms of mini esthetics, posed smiles will be analyzed to evaluate maxillary gingival display, as well as the analysis of smile arc, buccal corridor, inter-labial gap. In terms of macro esthetics, frontal and profile poses will be assessed to evaluate the nasolabial angle, mentolabial angle and upper and lower lip protrusion/ E- plane.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

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; Six anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain	Procedure: En-masse retraction; 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
Experimental: two step retraction; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macro-esthetics evaluation of profile photograph including	1. Nasolabial angle. 2. Mentolabial angle. 3. Incisors Inclination (Angular measurement in degrees). 4. Upper lip protrusion/ E- plane. 5. Lower lip protrusion/ E- plane. (Linear measurement in millimeters.) Cephalometric radiographs and Adobe Photoshop CC 2017 software	upto 6 months from the start of orthodontic treatment.

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Director: Yehya mostafa, Professor and chairman, Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Anticipated): December 28, 2021
• Study Completion (Anticipated): December 28, 2021

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: En-masse Retraction; Two step retraction; Lateral Cephalometric Radiographs; Mini-esthetics; Macro-esthetics; Extra-oral photographs; Adobe photoshop CC 2017 software
• Other Study ID Numbers: FUE.REC(26)/12-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No