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

Orthodontic Appliance Complication Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03653078
• Other study ID #: CEBD-CU-2018-08-27
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: Hadir Abo shady, MD
• Phone: 00201001937931
• Email: hadiraboshady[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

Device:
• Three dimensional printed digital guide
A CAD/CAM printed plate with a channel for mini-screw insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root proximity	Distance between inserted mini screw and the adjacent roots in microns	immediately after mini-screw insertion (T0)
Secondary	Patient discomfort:	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	immediately after mini-screw insertion (T0)