Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.

The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

Study Overview

• Status: Active, not recruiting
• Conditions: Bimaxillary Protrusion
• Intervention / Treatment: Procedure: Power chain and Crimpable hook fro En-masse Retraction; Procedure: T-loop

Detailed Description

One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.

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

Contacts and Locations

Study Locations

• Egypt
  • Future University In Egypt
    • Cairo, Future University In Egypt, Egypt
      • Amr Attia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Orthodontic patients (both genders)
2. Age range (14-24)
3. Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
4. Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
5. Cases requiring maximum anchorage during anterior segment retraction.
6. Cases with minimal crowding (2-3) mm

Exclusion Criteria:

1. Patients suffering from any systemic diseases interfering with tooth movement.
2. Patients with extracted or missing permanent teeth. (except for third molars).
3. Patients with badly decayed teeth.
4. Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc....).
5. Patients with previous orthodontic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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 212 g per side ) extending between the crimpable hooks and the miniscrew	Procedure: Power chain and Crimpable hook fro En-masse Retraction; Retraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew
EXPERIMENTAL: T-loop; Closing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine.	Procedure: T-loop; closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anchorage loss	Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )	from pre to post retraction/intervention ( an average of 6-8 months )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retraction Rate	The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitally scanned dental models taken of the patients monthly ( measured in mm )	from pre to post retraction/intervention ( an average of 6-8 months )
Molar Rotation	Digitally scanned dental models that are taken before and after retraction will be assess the rotation of the maxillary first permanent molar in relation to a reference line ( measurement of the angles in degrees )	from pre to post retraction/intervention ( an average of 6-8 months )
Pain of Intervention	each patient will fill a questionnaire regarding his treatment experience in a Visual Analog Scale (VAS) scoring from 1-10 by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The question-naire will include several questions related to oral hygiene, pain and discomfort experienced throughout the trial.	from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth extrusion/intrusion	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in mm )	from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth torque	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )	from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth tip	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )	from pre to post retraction/intervention ( an average of 6-8 months )

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 29, 2020
• Primary Completion (ANTICIPATED): January 29, 2022
• Study Completion (ANTICIPATED): January 29, 2022

Study Registration Dates

• First Submitted: May 15, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (ACTUAL): May 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: CBCT; Dental models; En-masse Retraction; Friction; Frictionless; Anchorage; Anchorage loss
• Other Study ID Numbers: FUE.REC (13)/7-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available after Publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; 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