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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653078
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hadir Aboshady, Cairo University

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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Device: Three dimensional printed digital guide Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: adult orthodontic participants
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.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 15, 2020

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.



Primary Outcome Measures :
  1. Root proximity [ Time Frame: immediately after mini-screw insertion (T0) ]
    Distance between inserted mini screw and the adjacent roots in microns


Secondary Outcome Measures :
  1. Patient discomfort: [ Time Frame: immediately after mini-screw insertion (T0) ]
    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



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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653078


Contacts
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Contact: Hadir Abo shady, MD 00201001937931 hadiraboshady@gmail.com
Contact: Mai Abo El fotouh, PHD 01001884499 maihamdi@gmail.com

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Hadir Aboshady, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03653078    
Other Study ID Numbers: CEBD-CU-2018-08-27
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadir Aboshady, Cairo University:
Surgical guide
Surgical stent
orthodontic mini screw
temporary anchorage device