Evaluation of Incisors' Position Following Anterior Segment Retraction

Evaluation of Incisors' Position Following Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.

Study Overview

• Status: Completed
• Conditions: Bimaxillary Protrusion
• Intervention / Treatment: Other: Power chain used for anterior segment retraction; Other: T-loop fabricated to perform anterior segment retraction

Detailed Description

Thirty females with bimaxillary protrusion were randomly allocated into two groups. In one group, anterior segment retraction was commenced using an elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. In the other group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. Three-dimensional analysis of incisors' buccolingual (BL)- torque, mesiodistal (MD)- tip, vertical position changes and root resorption were assessed using cone beam computed tomography scans.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients (Age 13- 25 y)
• Class I molar relation (Angle's classification)
• Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
• full permanent dentition (except 3rd molars)
• Good general and oral health

Exclusion Criteria:

• Systemic disease or syndromes or on anti-inflammatory medication.
• Extracted or missing permanent teeth (other than 3rd molars)
• Badly decayed teeth (other than 1st premolars)
• Parafunctional habits
• History of previous orthodontics treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior segment retraction using sliding mechanics (friction); Power chain	Other: Power chain used for anterior segment retraction; Elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor.
Experimental: Anterior segment retraction using segmental mechanics (frictionless); T-loop	Other: T-loop fabricated to perform anterior segment retraction; In the frictionless group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Torque of the incisors	The change of the outer angle between long axis of each upper anterior tooth and palatal plane on CBCT pre and post retracation and the change in the outer angle between long axis of each lower anterior tooth and horizontal plane on CBCT pre and post retracation	through study completion (Pre/post retraction), an average of 6 months
Tip of the incisors	The change of the angle between the long axis of the incisors and mid-sagittal plane on CBCT pre and post retracation	through study completion (Pre/post retraction), an average of 6 months
Vertical changes of the incisors	The change of the linear distance between the centroid of each maxillary anterior tooth and palatal Plane on CBCT pre and post retracation and The change of the linear distance between centroid of each mandibular anterior tooth and horizontal Plane on CBCT pre and post retracation	through study completion (Pre/post retraction) , an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root resorption of the anterior teeth	measuring the amount of resorption using CBCT in mm pre and post retraction	through study completion (Pre/post retraction), an average of 6 months

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): December 13, 2020

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: CBCT; friction; frictionless; anterior segment retraction; T loop
• Other Study ID Numbers: FUE.REC 11/10-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Data will be ready to share 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