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Clinical Trials/NCT03653078
NCT03653078UnknownNot Applicable

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

Cairo University0 sites30 target enrollmentStarted: November 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Primary Endpoint
Root proximity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

during the insertion procedure the principle investigator and the co supervisor couldn't be blinded, as the two insertion techniques are completely different.

Eligibility Criteria

Ages
14 Years to 45 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Three dimensional printed digital guide

Experimental

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

Intervention: Three dimensional printed digital guide (Device)

Conventional free hand insertion

No Intervention

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.

Outcomes

Primary Outcomes

Root proximity

Time Frame: immediately after mini-screw insertion (T0)

Distance between inserted mini screw and the adjacent roots in microns

Secondary Outcomes

  • Patient discomfort:(immediately after mini-screw insertion (T0))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hadir Aboshady

Principle investigator

Cairo University

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