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

NCT06934161 | Completed DMC

• 1 other identifier: URomLS_Thermography
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Quantitative Surface Temperature Assessment via Smartphone-Based Infrared Thermography.

  The measurement, done using smartphone-based thermal camera, involves capturing standardized baseline and follow-up thermal images of defined body regions (in this case attached gingiva and oral mucosa), with temperature values recorded as the mean of three consecutive readings. The data will be further aggregated using mean and standard deviation metrics for comparative analysis over time and between study groups.

  From the start to the end of the surgical treatment

Study Arms (2)

static computer-guided surgery

ACTIVE COMPARATOR

Procedure: static computer-guided Corticotomy; Diagnostic Test: smartphone-based thermography

dynamic computer guided-surgery

EXPERIMENTAL

Procedure: dynamic computer-guided Corticotomy; Diagnostic Test: smartphone-based thermography

Interventions

dynamic computer-guided Corticotomy PROCEDURE

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

dynamic computer guided-surgery

static computer-guided Corticotomy PROCEDURE

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

static computer-guided surgery

smartphone-based thermography DIAGNOSTIC_TEST

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).

dynamic computer guided-surgery; static computer-guided surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• uncontrolled systemic disease;
• syndromic patients;
• smoking habit;
• periodontal disease.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Oral and Maxillofacial Sciences Sapienza University of Rome

Rome, RM, 00161, Italy

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 18, 2025
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)