Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060981) titled 'Development of a radiation dose reduction method for cone-beam CT for dental use with small-data MTANN AI imaging' on March 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Double blind -all involved are blinded Control - Dose comparison

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - A research of Cone-beam CT imaging for periodontitis. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Cone-beam CT for dental use (CBCT) is widely used in dental care, but it tends to result in higher patient radiation doses compared to other X-ray examinations such as periapical radiography and panoramic radiography. In this study, we applied a Massive Training Artificial Neural Network (MTANN), a small-data AI, to CBCT images and developed an AI model that predicts high-dose images even under low-dose conditions. The purpose of this study is to investigate whether this AI model is effective for actual clinical images. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - From June 2025 to March 2028, patients who visit the periodontal disease outpatient clinic at Institute of Science Tokyo Hospital and meet the criteria of Section 4.2 of the research protocol (selection policy for research subjects) will undergo low-dose radiography in addition to standard clinical dose radiography. The planned number of cases is 60. Interventions/Control_2 - From June 2025 to March 2028, patients who visit the periodontal disease outpatient clinic at Institute of Science Tokyo Hospital and meet the criteria of Section 4.2 of the research protocol (selection policy for research subjects) will undergo low-dose radiography in addition to standard clinical dose radiography. The planned number of cases is 60.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Individuals with a clinical indication requiring dental CBCT imaging. Individuals aged 20 to under 80 years old at the time of obtaining consent. Individuals who have provided written consent to participate in the study. Gender is not a factor. Key exclusion criteria - Pregnant or breastfeeding individuals. Individuals with severe renal impairment. Other individuals deemed unsuitable by the principal investigator or co-investigators. Target Size - 60

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 19 Day Date of IRB - 2025 Year 02 Month 20 Day Anticipated trial start date - 2026 Year 04 Month 02 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069781

Disclaimer: Curated by HT Syndication.