drugset / Trial / NCT07374354

Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

NCT07374354

RandomizedParallel-groupTriple-blindPrevention

Summary

This randomized, triple-blinded clinical trial aims to evaluate the effect of preemptive analgesia using ibuprofen on pain perception and anxiety during restorative treatment of first permanent molars in children diagnosed with molar-incisor hypomineralization (MIH). MIH-affected teeth often present with hypersensitivity, difficulty in achieving adequate anesthesia, and increased dental anxiety, which complicates dental treatment. Participants aged 6-12 years with MIH will receive either ibuprofen syrup or placebo 30 minutes before treatment. Pain will be assessed using the FLACC Behavioral Pain Scale and Wong-Baker FACES scale, and anxiety will be evaluated through heart rate and oxygen saturation. The results will determine whether preoperative ibuprofen reduces intraoperative pain and improves anxiety control in this population.

Timeline

Start
2026-02
Primary completion
2026-02
Completion
2026-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 100 mg/ml Oral

Indications

No indication recorded.