Comparing intraosseous and infiltration anesthesia for children with MIH
Official title: A Comparative Evaluation of the Clinical Effectiveness of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children With Molar-Incisor Hypomineralization
Run by Ankara Yildirim Beyazıt University · NCT07352813 · Data updated 2026-11-12
We will test whether intraosseous or infiltration anesthesia delivered with a computer-assisted device better reduces pain and anxiety during fillings of permanent first molars in children with MIH.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ankara Yildirim Beyazıt University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | November 7, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07352813 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 who are systemically healthy, score 3–4 on the Frankl behavior scale, have contralateral maxillary first molars affected by MIH with non-pulpal carious lesions, and whose guardians consent to three clinic visits are ideal candidates.
✕Probably not a fit
Children with pulp-involved lesions, severe uncooperative behavior (Frankl <3), systemic illnesses, known anesthetic allergies, or inability to attend required in-person visits 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
Thirty children aged 6–12 with MIH affecting contralateral maxillary first permanent molars will be enrolled and randomized to the order of two anesthesia techniques delivered with the SleeperOne® computer-assisted system. Treatments will occur across three sessions at least one week apart, with restorative procedures performed on matched molars using either intraosseous or infiltration anesthesia. Pain and behavioral responses will be measured by Visual Analogue Scale (VAS), behavioral ratings, pulse rate, salivary chromogranin A, and the need for additional anesthesia. The trial will compare clinical effectiveness and supplemental anesthesia requirements between the two techniques.
Why it matters
Potential benefit: If successful, the preferred technique could provide faster, more reliable pain control with less anxiety and fewer extra injections for children with MIH during restorative care.
How similar studies have gone: Prior pediatric dentistry studies show intraosseous and computer-assisted infiltration techniques can improve local anesthesia effectiveness and reduce pain, but direct comparisons specifically in MIH-affected permanent molars are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry, * Systemically healthy individuals, * Individuals without any known allergies, * Children between the ages of 6 and 12 years, * Scoring 3-4 according to the Frankl Behavior Rating Scale, * Children and their legal guardians who, after reading and listening to the informed consent form, fully understand its content and voluntarily provide both verbal and written consent, * Children with contralateral and homologous maxillary first permanent molars affected by molar-incisor hypomineralization (MIH) and scoring 3-4 according to the MIH Treatment Need Index criteria, * Children with no emergency treatment needs, such as dental pain, * Both male and female volunteers. Exclusion Criteria: \-
Where it's running
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Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Gülsevim Oda, Assistant professor, pHD
- Email: gulsevimoda@aybu.edu.tr
- Phone: 90538948890
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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.