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

NCT06934161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

  • Orthodontic Tooth Movement
  • Burn Injury

Interventions

PROCEDURE

dynamic computer-guided Corticotomy

corticotomy cuts were made guided by a dynamic navigation system, ensuring accuracy and reducing the risk of injuries

PROCEDURE

static computer-guided Corticotomy

corticotomy cuts were made guided by a static system (using reticulated surgical template), ensuring accuracy and reducing the risk of injuries

DIAGNOSTIC_TEST

smartphone-based thermography

a Mini2 Infrared Smartphone Camera (Hangzhou HIKMICRO Sensing Technology Co., China) was initially calibrated with the surrounding ambient temperature. The calibration phase was essential as it enabled the device's algorithm to have a reference point based on the surrounding conditions and eliminate any bias caused by varying environmental temperatures. Then, pre-operative temperatures of attached gingiva and alveolar mucosa surfaces were recorded. The measurements were registered by distinguishing, for both arches, the temperature corresponding to soft tissues from incisor region (from central incisor to homolateral canine), premolar region (first and second premolars), and molar region (first and second molars).

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2024-12-01
Completion
2025-03-31

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 NCT06934161 on ClinicalTrials.gov