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.
October University for Modern Sciences and Arts
46 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Patient with molar incisor hypo-mineralization.
- Patient's age ranges from 6 to 12 years old.
- The affected tooth has demarcated opacity with post eruptive enamel breakdown.
- No cavitated lesion is related to the defect of previous restorative or preventive treatment.
Exclusion Criteria4
- Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention.
- Loss of tooth structure due to caries.
- intolerance to ibuprofen.
- developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT07374354