NCT03653078

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 28, 2018

Last Update Submit

August 28, 2018

Conditions

Orthodontic Appliance Complication

Keywords

Surgical guideSurgical stentorthodontic mini screwtemporary anchorage device

Outcome Measures

Primary Outcomes (1)

  • Root proximity

    Distance between inserted mini screw and the adjacent roots in microns

    immediately after mini-screw insertion (T0)

Secondary Outcomes (1)

  • Patient discomfort:

    immediately after mini-screw insertion (T0)

Study Arms (2)

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

Device: Three dimensional printed digital guide

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.

Interventions

Three dimensional printed digital guideDEVICE

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

Also known as: surgical guide, surgical stent
Three dimensional printed digital guide

Eligibility Criteria

Age14 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23726340BACKGROUND

  • 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.

    PMID: 18486791BACKGROUND

Central Study Contacts

Hadir Abo shady, MD

CONTACT

00201001937931hadiraboshady@gmail.com

Mai Abo El fotouh, PHD

CONTACT

01001884499maihamdi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
during the insertion procedure the principle investigator and the co supervisor couldn't be blinded, as the two insertion techniques are completely different.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: adult orthodontic participants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

November 15, 2018

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

August 31, 2018

Record last verified: 2018-08