Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide

Orthodontic Appliance Complication Clinical Trial

Official title: Evaluation of Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide Versus Conventional Free Hand Placement Technique in Adult Orthodontic Patients A Split Mouth Randomized Clinical Trial

Status Not yet recruiting

Clinical Trial Summary

Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.

Clinical Trial Description

PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique

• O: Primary outcome: Root proximity

Secondary outcomes:

• Patient discomfort during insertion 17

• Insertion accuracy

• Angular deviation

• Linear deviation

• Failure 18 S: Split Mouth Randomized clinical Trial ;

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

• NCT number: NCT03653078
• Study type: Interventional
• Source: Cairo University
• Contact: Hadir Abo shady, MD
• Phone: 00201001937931
• Email: hadiraboshady@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2018
• Completion date: January 15, 2020