CompletedNot Applicable

Comparison of the Effectiveness of Innovative Techniques to Prevent Tissue Overheating During Corticotomy Using Smartphone-Based Thermography: Reticulated Surgical Guide vs Dynamic Navigation.

Italy4 participantsStarted 2024-10-01

Plain-language summary

Objectives: The aim of the present split-mouth randomized clinical trial was to compare the effectiveness of two innovative corticotomy techniques, using reticulated static computer-guided surgery and dynamic computer-guided surgery, in terms of prevention of tissue overheating. Material and Methods: Four adult subjects requiring accelerated orthodontic treatment were enrolled. Each subject received both interventions in different quadrants. Preoperative surgical planning involved cone-beam computed tomography (CBCT) and optical scanning to superimpose DICOM and STL files. The static technique utilized a digitally designed reticulated surgical guide featuring multiple irrigation holes, while the dynamic technique employed a navigation system to provide real-time guidance. Preoperative, intraoperative and immediate postoperative tissue temperatures were recorded using an infrared smartphone camera. Statistical analyses, including Student's t-test, Mann-Whitney, and Welch tests, were performed to assess differences in thermographic measurements.

Who can participate

Age range

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: * age \>18 years, * need for orthodontic treatment and request of short-term orthodontic treatment, * good oral hygiene, * absence of systemic and oral cavity acute infection, * good general health. Exclusion Criteria: * uncontrolled systemic disease; * syndromic patients; * smoking habit; * periodontal 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

Quantitative Surface Temperature Assessment via Smartphone-Based Infrared Thermography.

Timeframe: From the start to the end of the surgical treatment

Trial details

NCT IDNCT06934161

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Orthodontic Tooth Movement trials