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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04878939
Other study ID # FUE.REC 11/10-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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