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

Cairo University (CU)

Status: Unknown

Conditions: Orthodontic Appliance Complication

Treatments: Device: Three dimensional printed digital guide

Study type: Interventional

Funder types: Other

Identifiers

NCT03653078

CEBD-CU-2018-08-27

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Three dimensional printed digital guide

Experimental group

Description:

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

Treatment:

Device: Three dimensional printed digital guide

Conventional free hand insertion

No Intervention group

Description:

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.