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

Not Applicable
Conditions
Orthodontic Appliance Complication
Interventions
Device: Three dimensional printed digital guide
Registration Number
NCT03653078
Lead Sponsor
Cairo University
Brief 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.

Detailed 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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle
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Exclusion Criteria
  • Mixed dentition patients

    • Smoker patients
    • Patients with Increased lower facial height
    • Patients with missing posterior teeth
    • Bleeding disorders or anticoagulant therapy
    • Patients with cleft lip & palate
    • Patients with facial asymmetry
    • Patients with transverse maxillary deficiency
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Three dimensional printed digital guideThree dimensional printed digital guideone mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using Three dimensional printed digital guide, which is a device deisgned and printed through CAD/CAM technology, it's a printed plate fit on the teeth and buccal mucosa with a channel for mini- screw insertion, mini-screw will be inserted through the plate's channel
Primary Outcome Measures
NameTimeMethod
Root proximityimmediately after mini-screw insertion (T0)

Distance between inserted mini screw and the adjacent roots in microns

Secondary Outcome Measures
NameTimeMethod
Patient discomfort:immediately after mini-screw insertion (T0)

Likert scale, it is scale divided into five points to measure the degree of patient discomfort maximum value(5) strongly discomfort, discomfort, neutral, little discomfort, and minimum value (0)no discomfort

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