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

NCT06661551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-10-28

No results posted yet for this study

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

Interventions

PROCEDURE

Miniscrew insertion in dynamic-computer guided surgery

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

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-09-01
Completion
2024-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661551 on ClinicalTrials.gov