Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion

Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion: A Randomized Clinical Trial

Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques

Study Overview

• Status: Completed
• Conditions: Bimaxillary Protrusion
• Intervention / Treatment: Procedure: En masse retraction; Procedure: Two-Step retraction

Detailed Description

Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these techniques results in a decreased treatment time is still up for debate.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11835
    • Future University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults and adolescent patients ( both gender)
• Age range (14- 24)
• patient 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 required maximum anchorage during retraction.
• good general and oral health

Exclusion Criteria:

• patients suffering from any systemic diseases interfering with tooth movement.
• 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 are retracted by en masse technique using a crimpable hook distal to upper lateral incisor and a power chain.	Procedure: En masse retraction; Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.
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 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 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to close extraction space	the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets	from pre to post retraction ( an average of 10 - 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anchorage loss	Digitalized dental models taken before and after completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm)	From pre to post retraction ( an average of 10- 12 months)
pain of intervention	Each patient was informed to fill a questionnaire regarding treatment experience in Visual analogue scale scoring from (0 -10) 0 means no pain and 10 means severe pain	From pre to post retraction ( an average of 10 - 12 months)

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: friction; En-masse retraction; two step retraction; retraction time; Dental models
• Other Study ID Numbers: FUE.REC (23)/11-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD sharing statement
• IPD Sharing Time Frame: Data will be available after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No