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Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

RecruitingNAAges 6 Years - 12 YearsAllOctober University for Modern Sciences and Arts
NCT07374354 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient with molar incisor hypo-mineralization. 2. Patient's age ranges from 6 to 12 years old. 3. The affected tooth has demarcated opacity with post eruptive enamel breakdown. 4. No cavitated lesion is related to the defect of previous restorative or preventive treatment. Exclusion Criteria: 1. Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention. 2. Loss of tooth structure due to caries. 3. intolerance to ibuprofen. 4. developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.
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What it tests

  • ibuprofen 100mg/ml oral suspension syrup
  • Placebo
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Where

1 site
October university of modern science and arts
Giza, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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