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

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

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.

Study Overview

• Status: Unknown
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: Three dimensional printed digital guide

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three dimensional printed digital guide; 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; A CAD/CAM printed plate with a channel for mini-screw insertion; Other Names: surgical guide; surgical stent
No Intervention: Conventional free hand insertion; 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?

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)

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Bae MJ, Kim JY, Park JT, Cha JY, Kim HJ, Yu HS, Hwang CJ. Accuracy of miniscrew surgical guides assessed from cone-beam computed tomography and digital models. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):893-901. doi: 10.1016/j.ajodo.2013.02.018.
• Suzuki EY, Suzuki B. Accuracy of miniscrew implant placement with a 3-dimensional surgical guide. J Oral Maxillofac Surg. 2008 Jun;66(6):1245-52. doi: 10.1016/j.joms.2007.08.047.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2018
• Primary Completion (Anticipated): December 15, 2019
• Study Completion (Anticipated): January 15, 2020

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Surgical guide; Surgical stent; orthodontic mini screw; temporary anchorage device
• Other Study ID Numbers: CEBD-CU-2018-08-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No