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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Orthodontic Appliance Complication

Intervention / Treatment
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* Device: Three dimensional printed digital guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: adult orthodontic participants
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three dimensional printed digital guide<br>one 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 | Device: Three dimensional printed digital guide<br>* A CAD/CAM printed plate with a channel for mini-screw insertion<br>* Other names: surgical stent;|
| No Intervention: Conventional free hand insertion<br>one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using conventional free hand insertion of mini-screw, which is a technique using the guiding anatomy for mini-screw insertion using the driver and the operator's skill. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root proximity | Distance between inserted mini screw and the adjacent roots in microns | immediately after mini-screw insertion (T0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort: | 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 | immediately after mini-screw insertion (T0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical guide, Surgical stent, orthodontic mini screw, temporary anchorage device