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

NCT ID: NCT03653078

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-01-15

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

Conditions

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Orthodontic Appliance Complication

Keywords

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Surgical guide Surgical stent orthodontic mini screw temporary anchorage device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

adult orthodontic participants
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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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

Group Type EXPERIMENTAL

Three dimensional printed digital guide

Intervention Type DEVICE

A CAD/CAM printed plate with a channel for mini-screw insertion

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Three dimensional printed digital guide

A CAD/CAM printed plate with a channel for mini-screw insertion

Intervention Type DEVICE

Other Intervention Names

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surgical guide surgical stent

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hadir Aboshady

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hadir Abo shady, MD

Role: CONTACT

Phone: 00201001937931

Email: [email protected]

Mai Abo El fotouh, PHD

Role: CONTACT

Phone: 01001884499

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23726340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18486791 (View on PubMed)

Other Identifiers

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CEBD-CU-2018-08-27

Identifier Type: -

Identifier Source: org_study_id