CompletedNot Applicable

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

Italy36 participantsStarted 2022-12-01

Plain-language 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

Who can participate

Age range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Syndromic patients; * Uncontrolled systemic disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Miniscrew insertion accuracy assessment

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

Trial details

NCT IDNCT06661551

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Malocclusion trials