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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pain and Anxiety in Children With MIH
• Intervention / Treatment: Drug: ibuprofen 100mg/ml oral suspension syrup; Drug: Placebo

Detailed Description

Molar-incisor hypomineralization (MIH) is a developmental enamel defect associated with post-eruptive breakdown, hypersensitivity, difficulty achieving effective anesthesia, increased dental anxiety, and a higher risk of restorative complications. Children with MIH require more frequent and complex dental care and often experience discomfort during treatment, negatively impacting their cooperation and oral-health-related quality of life.

Preemptive analgesia-the administration of analgesics before starting dental procedures-has shown promise in reducing nociceptive transmission and improving anesthetic efficacy. Previous studies have evaluated the effect of ibuprofen on pain during dental procedures in MIH-affected children, but evidence remains limited, and anxiety-related outcomes have not been comprehensively assessed.

This triple-blinded randomized controlled trial will include children aged 6-12 presenting with MIH and post-eruptive enamel breakdown but without carious lesions or prior restorations. Participants will be randomly assigned (1:1) to receive either ibuprofen 100 mg syrup or a matching placebo 30 minutes before treatment. All procedures will be performed under standardized conditions, including local anesthesia with articaine 4%, rubber dam isolation, and restorative treatment by trained pediatric dentists.

Pain perception will be recorded using both objective and subjective metrics. Objective pain will be evaluated using the FLACC Behavioral Pain Scale during anesthesia and treatment. Subjective pain will be assessed using the Wong-Baker FACES scale at predefined time points before, during, and after treatment. Dental anxiety will be monitored using physiological indicators: heart rate and oxygen saturation measured with a pulse oximeter at baseline, during, and after the dental procedure.

The primary objective is to determine whether preemptive ibuprofen reduces behavioral pain responses during treatment. Secondary objectives include assessing self-reported pain and physiologic anxiety measures. The findings aim to guide pediatric clinicians in improving pain control, reducing treatment-related anxiety, and enhancing the overall management of children with MIH.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12611
    • Recruiting
    • October university of modern science and arts
    • Contact: Esraa Diaaeldin Elhenie, bachelor; Phone Number: 00201094007206; Email: ediaaeldin@msa.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ibuprofen 100mg/ml oral suspension syrup; The analgesic will be labeled A; (ibuprofen 100 mg/ml oral suspension). Administration of analgesic will be 30 mins prior to procedure. The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure. Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000. Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established.	Drug: ibuprofen 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.
Placebo Comparator: placebo; The placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration of placebo will be 30 mins prior to procedure. The Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure. Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000. Rubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established.	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception (objective)	Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	during injection and during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain perception (subjective)	Wong Baker FACES Pain Rating Scale. It consists of several faces ranging from happy (0) to crying (10).	Initial before procedure (baseline) After drug/placebo administration (30 min), Before anesthesia, After anesthesia, During the procedure (real-time) 24 hours after the end of the procedure (post-operative)
dental anxiety	pulse oximeter (heart rate monitor) unit: Beat/ minute	initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)
dental anxiety	pulse oximeter oxygen saturation unit: percentage	initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ibuprofen; Dental Anxiety; Dental Pain; Analgesic Efficacy; Preemptive Analgesia; Molar Incisor Hypomineralization (MIH); FLACC Scale; Wong-Baker FACES; Post-Eruptive Enamel Breakdown; Children 6-12 Years
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Facial Pain; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Molar Hypomineralization; Pain; Toothache; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Phenylpropionates; Ibuprofen
• Other Study ID Numbers: Esraa MSA University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No