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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bimaxillary Protrusion

Intervention / Treatment
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* Procedure: En-masse retraction
* Procedure: Two step Retraction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: En-Masse Retraction<br>Six anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain | Procedure: En-masse retraction<br>* Power chain and Crimpable hook for En-Masse Retraction Retraction will start on a 0.017x0.025 Stainless steel wire using elastomeric chain (force applied will be 200 g per side) extending between the crimpable hooks and the miniscrew<br>|
| Experimental: two step retraction<br>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<br>* Retraction of canine started on a 0.017x0.025 Stainless steel wire using elastomeric chain (force applied will be 150 g per side)followed by anterior teeth retraction on 0.017x0.025 Stainless steel wire using elastomeric chain (force applied will be 160 g per side) extending between the crimpable hooks and the mini-screw.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini-esthetics, Macro-esthetics, En-masse Retraction, Two step retraction, Extra-oral photographs, Adobe photoshop CC 2017 software, Lateral Cephalometric Radiographs