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

NCT03653078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Orthodontic Appliance Complication

Interventions

DEVICE

Three dimensional printed digital guide

A CAD/CAM printed plate with a channel for mini-screw insertion

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-12-15
Completion
2020-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653078 on ClinicalTrials.gov