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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653078
Enrollment
30
Registered
2018-08-31
Start date
2018-11-15
Completion date
2020-01-15
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance Complication

Keywords

Surgical guide, Surgical stent, orthodontic mini screw, temporary anchorage device

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

Interventions

DEVICEThree dimensional printed digital guide

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

Intervention model description

adult orthodontic participants

Eligibility

Sex/Gender
ALL
Age
14 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Root proximityimmediately after mini-screw insertion (T0)Distance between inserted mini screw and the adjacent roots in microns

Secondary

MeasureTime frameDescription
Patient discomfort: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

Contacts

Primary ContactHadir Abo shady, MD
hadiraboshady@gmail.com00201001937931
Backup ContactMai Abo El fotouh, PHD
maihamdi@gmail.com01001884499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026