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

Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05150665
• Other study ID #: FUE.REC(26)/12-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 29, 2020
• Est. completion date: December 28, 2021

Study information

• Verified date: November 2021
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Future University In Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.