Preemptive ibuprofen to reduce pain and anxiety during dental treatment for children with MIH
Official title: 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.
Run by October University for Modern Sciences and Arts · NCT07374354 · Data updated 2026-11-12
This trial will test whether a single dose of ibuprofen given 30 minutes before restorative treatment helps children aged 6–12 with MIH experience less pain and anxiety during the procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (Giza) |
| Status | Recruiting |
| Started | February 2026 |
| Main results expected | February 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07374354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 with MIH affecting first permanent molars with post-eruptive enamel breakdown but no cavitated carious lesions or prior restorations and no intolerance to ibuprofen are ideal candidates.
✕Probably not a fit
Children with active carious lesions on the affected tooth, prior restorations, known ibuprofen intolerance, or significant medical or developmental conditions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, triple-blinded trial will assign children aged 6–12 with MIH and post-eruptive enamel breakdown to receive either ibuprofen 100 mg syrup or a matching placebo 30 minutes before restorative treatment of first permanent molars. All procedures use standardized local anesthesia with articaine, rubber dam isolation, and are performed by trained pediatric dentists while clinicians and families remain blinded. Pain will be recorded using the FLACC Behavioral Pain Scale and Wong‑Baker FACES, and anxiety will be monitored by heart rate and oxygen saturation. The study will compare subjective and objective pain and physiological anxiety measures between the ibuprofen and placebo groups to see if preemptive analgesia improves intraoperative comfort and cooperation.
Why it matters
Potential benefit: If successful, giving ibuprofen before treatment could reduce pain and lower dental anxiety in children with MIH, making procedures easier and more comfortable.
How similar studies have gone: Previous small studies have suggested preemptive ibuprofen can reduce dental pain in children, but the evidence is limited and anxiety outcomes have not been comprehensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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October university of modern science and arts
Giza, Egypt Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.