Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07374354

Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

Led by October University for Modern Sciences and Arts · Updated on 2026-01-28

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Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with molar incisor hypo-mineralization
  • Age between 6 and 12 years old
  • Affected tooth shows demarcated opacity with post-eruptive enamel breakdown
  • No cavity or prior restorative or preventive treatment related to the defect
Not Eligible

You will not qualify if you...

  • Children with physical or mental disabilities or medical conditions affecting intervention assessment
  • Loss of tooth structure due to caries
  • Intolerance to ibuprofen
  • Developmental tooth defects such as amelogenesis imperfecta or dentinogenesis imperfecta

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

October university of modern science and arts

Giza, Egypt, 12611

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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