Preemptive Analgesia for Pain and Anxiety Control in Children With MIH

NCT07374354 | Recruiting DMC

• 1 other identifier: Esraa MSA University
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain and Anxiety in Children With MIH

Keywords

Molar Incisor Hypomineralization (MIH); Preemptive Analgesia; Ibuprofen; Dental Pain; Dental Anxiety; FLACC Scale; Wong-Baker FACES; Post-Eruptive Enamel Breakdown; Children 6-12 Years; Analgesic Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• pain perception (subjective)

  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

  initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)

• dental anxiety

  initial before treatment (baseline), during anesthesia, during treatment (real-time) and immediately after treatment (post-operative)

Study Arms (2)

ibuprofen 100mg/ml oral suspension syrup

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

ibuprofen 100mg/ml oral suspension syrup DRUG

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.

ibuprofen 100mg/ml oral suspension syrup

Placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

October university of modern science and arts

Giza, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Pain; Molar Hypomineralization; Toothache

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Facial Pain

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general practitioner

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)