Does the Generation to Which the Operator Belongs Influence the Orthodontic Miniscrew Insertion Accuracy in Dynamic Computer-guided Surgery?

NCT06661551 | Completed

• 1 other identifier: URomLS_5951
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to access the miniscrew accuracy insertion via dynamic computer-guided systems, inserted by three different clinicians belonging to three different generations, in childern in late mixed dentition or permanent dentition that need for orthodontic treatment, with good oral hygiene and absence of acute infection in the oral cavity and good general healt. The main questions it aims to answer are:

• Are there statistically significant differences between accuracy parameters and generation to which the clinician belongs?
• Does exist a significant correlation between the deviation parameters and the number of surgeries, and between the duration of interventions and the number of surgeries? Researchers wirll compare the deviation parameters to see if there are statistically significant differences in terms of accuracy. Participants will undergo a surgical procedure of placement of 2 orthodontic miniscrews in the palatal region, and then a post-operative CBCT to assess the accuracy and presence or absence of damage to adjacent structures

Conditions

Malocclusion; Malocclusion in Children; Malocclusion; Displaced or Missing Teeth

Keywords

Dynamic computer-guided surgery; navigation systems; TADs; generations; accuracy

Outcome Measures

Primary Outcomes (1)

• Miniscrew insertion accuracy assessment

  The preoperative and postoperative DICOM images need to be superimposed, through the use of EvaluNav software (ClaroNav Technology Inc., Toronto, Canada), employing coordinated automatically given by the software. The software, to assess the differences between the planned position and the actual placement of miniscrews, will provide five deviation parameters: Entry-3D, Entry-2D, Apex-3D, Apex vertical (vertical deviation), Angular deviation. Entry 2D: deviation of the miniscrew platform in the x and y dimensions of space in an occlusal view; Entry 3D: deviation of the miniscrew platform in the three dimensions of space; Apex 3D: deviation of the miniscrew apex in the three dimensions of space; Apex vertical: deviation of miniscrew apex depth (z-axis), in millimeters (mm); Angle: angular deviation between the central axes of the planned position and the final position, in degrees (°).

  Through study completion, and average of 1 year and a half

Secondary Outcomes (1)

• Correlation between the deviation parameters and the number of surgeries, and between the duration of interventions and the number of surgeries.

  Through study completion, and average of 1 year and a half

Study Arms (3)

Group A (Generation X operator)

EXPERIMENTAL

Group A is going to be treated by operator number 1, an oral surgeon with more than 30 Years of experience, which belongs to "Generation X"

Procedure: Miniscrew insertion in dynamic-computer guided surgery

Group B (Generation Y operator)

EXPERIMENTAL

Operator number 2 (MG) will treat Group B and is a dentist with 15 years of experience in oral surgery and belonged to "Generation Y".

Procedure: Miniscrew insertion in dynamic-computer guided surgery

Group C (Generation Z operator)

EXPERIMENTAL

Group C will be treated by operator number 3 (DB), a final year dental student with no previous experience in oral surgery, that belonged to "Generation Z".

Procedure: Miniscrew insertion in dynamic-computer guided surgery

Interventions

Miniscrew insertion in dynamic-computer guided surgery PROCEDURE

The intervention more executed in the literature is by using static computer-guided systems (s-CAS) . However, the s-CAS has limitations, including the time and cost associated with guide production, furthermore, the guide's bulk prevents its use in patients with limited mouth opening, and reduced irrigation potentially leads to overheating and bone burns during implant placement. Additionally, the inability to adjust the surgical plan intraoperatively, the lack of real-time visualization during implant site preparation and implant insertion, and the requirement for specific surgical kits for each implant system present further challenges. Dynamic navigation systems offer several benefits as highlighted in the literature, including: real-time feedback of the position of surgical drill or implant, allowing intraoperative changes adjusting the implant position during the surgery, reduction of risk of injury to adjacent anatomical structures, promotion of accuracy in novices

Group A (Generation X operator); Group B (Generation Y operator); Group C (Generation Z operator)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children in late mixed dentition or permanent dentition;
• Need for orthodontic treatment;
• Good oral hygiene;
• Absence of acute infection in the oral cavity;
• Good general health.

You may not qualify if:

• Syndromic patients;
• Uncontrolled systemic disease.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, Italy, 00161, Italy

Location

Related Publications (3)

• Brilli D, Cauli I, Cassetta M. How palatal vault morphology and screw length influence the accuracy of dynamic computer-guided orthodontic miniscrew insertion. A prospective clinical study. J Dent. 2024 Jul;146:105093. doi: 10.1016/j.jdent.2024.105093. Epub 2024 May 22.

  PMID: 38788916 BACKGROUND

• S. Bertoldo, D. Brilli, I. Cauli, M. Cassetta, Dynamic navigation for miniscrew insertion in the palatal vault: a pilot study, Dental Cadmos 7 (2024). https://doi.org/10.19256/d.cadmos.07.2024.06.

  BACKGROUND

• Brilli D, Giansanti M, Cassetta M. Does the operator's generational cohort influence the accuracy of orthodontic miniscrews insertion in the palatine vault in dynamic computer-guided surgery? A randomized prospective study. Oral Maxillofac Surg. 2025 Jun 10;29(1):120. doi: 10.1007/s10006-025-01414-7.

  PMID: 40493264 DERIVED

MeSH Terms

Conditions

Malocclusion; Anodontia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Full Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)