Evaluation of Incisors' Position Following Anterior Segment Retraction

Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878939
• Other study ID #: FUE.REC 11/10-2018
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: December 13, 2020

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 13, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

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.
• 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.

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	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
Primary	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
Primary	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	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