Last reviewed · How we verify
NCT07374354
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.
NA trial testing ibuprofen 100mg/ml oral suspension syrup in Pain and Anxiety in Children With MIH in 46 participants. Currently enrolling.
1 February 2026
Quick facts
| Lead sponsor | October University for Modern Sciences and Arts |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 46 |
| Start date | 1 February 2026 |
| Primary completion | 1 February 2026 |
| Estimated completion | 1 February 2026 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- ibuprofen 100mg/ml oral suspension syrup — full drug profile →
- Placebo
Conditions studied
- Pain and Anxiety in Children With MIH — all drugs for Pain and Anxiety in Children With MIH →
Sponsor
October University for Modern Sciences and Arts
Who can join
Adults 6 to 12, any sex, with Pain and Anxiety in Children With MIH. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pain perception (objective)
Time frame: during injection and during procedure
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07374354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other October University for Modern Sciences and Arts trials
Trials by the same sponsor.
- NCT07437794 — Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary M · NA · not yet recruiting
- NCT07395401 — Evaluation of Zinc Oxide Eugenol and Iodoform-Calcium Hydroxide as Filling Materials in Primary Molar Root Canals Prepar · NA · recruiting
- NCT07382245 — Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Yo · NA · not yet recruiting
- NCT07245030 — Effectiveness of Virtual Reality vs Show-Do Technique on Dental Anxiety in Children With Hearing Impairment · NA · recruiting
- NCT07432165 — Artificial Intelligence Versus Conventional Digital Design for Fixed Dental Prosthesis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07374354 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by October University for Modern Sciences and Arts
- Last refreshed: 25 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07374354.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing