Clinical Trial

Association Between Lingual Retraction and Hemodynamic Changes in Patients Receiving Dental Treatment Under General Anesthesia

Completed
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Summary
This study aims to investigate the association between sudden decreases in heart rate and blood pressure during dental procedures requiring lingual retraction-such as fillings, root canal treatments, tooth extractions, and cyst surgeries-under general anesthesia. Patients will be routinely monitored for vital parameters during anesthesia. Sudden drops in heart rate and blood pressure (10-20% decrease) will be recorded as lingual retraction-related trigeminocardiac reflex (TCR) events, along with the type of lingual retraction, dental procedure, and tooth location at the time of occurrence. Additionally, the results will be analyzed in relation to patient age, sex, and tongue size. \*\*Amendment \[March 2026\]:\*\* Following protocol revision and ethics committee approval, the study population has been restricted to pediatric patients (aged 2-18 years), and the adult arm has been discontinued. The primary outcome and observational methodology remain unchanged; however, the secondary outcome regarding adult-pediatric comparison has been removed from the analysis plan.\*\*
Protocol Amendment History 4 changes
critical Trial completed 2026-04-10
minor Trial arms changed: 2 -> 1 2026-04-10
notable Primary completion moved earlier: 2026-08-13 -> 2026-03-27 2026-04-10
minor Completion moved earlier: 2026-10-13 -> 2026-03-27 2026-04-10
Trial Details
NCT Number NCT07240688
Lead Sponsor Kırıkkale University
Conditions Trigeminocardiac Reflex, Hemodynamic Changes, Dental Procedures
Enrollment 85 participants
Start Date 2025-10-13
Primary Completion 2026-03-27 (estimated)
Study Completion 2026-03-27 (estimated)
Updated on ClinicalTrials.gov 2026-04-09