RecruitingNot ApplicableNCT07374354

Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

Assessment of Preemptive/Preoperative Analgesia Effect on Pain Perception and Anxiety Management in Children With Molar Incisor Hypo-Mineralization During Restorative Treatment of First Permanent Molar: A Triple-Blinded Randomized Clinical Trial.

Sponsor

October University for Modern Sciences and Arts

Enrollment

46 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Pain and Anxiety in Children With MIH

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.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a pain reliever (preemptive analgesia with ibuprofen or similar medication) before a dental procedure can reduce pain and anxiety in children aged 6 to 12 who have molar incisor hypomineralization (MIH) — a condition where the enamel on certain teeth is softer and more sensitive than normal. **You may be eligible if...** - Your child is between 6 and 12 years old - Your child has been diagnosed with molar incisor hypomineralization (MIH) - The affected tooth has visible discoloration or weakened enamel that has broken down after eruption - The tooth has not previously been treated with a filling or other restoration related to MIH **You may NOT be eligible if...** - Your child has a physical or mental disability that could interfere with the study - Tooth structure has been lost due to tooth decay (cavities) - Your child is intolerant or allergic to ibuprofen - Your child has other developmental enamel conditions such as amelogenesis or dentinogenesis imperfecta Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGibuprofen 100mg/ml oral suspension syrup

ibuprofen 100 mg/ml oral suspension administration 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.

DRUGPlacebo

the placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration placebo will be 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.

Locations(1)

October university of modern science and arts

Giza, Egypt

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NCT07374354