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

Sponsor

Future University in Egypt (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05150665

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bimaxillary Protrusion	Procedure: En-masse retraction Procedure: Two step Retraction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 29, 2020

Anticipated Primary Completion Date :

Dec 28, 2021

Anticipated Study Completion Date :

Dec 28, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mini-esthetics including [From pre to post retraction (an average of 6 - 8 months)]]
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.

Secondary Outcome Measures

Macro-esthetics evaluation of profile photograph including [upto 6 months from the start of orthodontic treatment.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.