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Recruiting NCT07352813

NCT07352813 Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children

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Clinical Trial Summary
NCT ID NCT07352813
Status Recruiting
Phase
Sponsor Ankara Yildirim Beyazıt University
Condition Molar Incisor Hypomineralization
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2025-11-07
Primary Completion 2026-11-07

Eligibility & Interventions

Sex All sexes
Min Age 6 Years
Max Age 12 Years
Study Type INTERVENTIONAL
Interventions
Intraosseous anaesthesia using a computerized systemInfiltration anaesthesia using a computerized system

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-11-07 with a primary completion date of 2026-11-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study aims to compare the effectiveness of intraosseous and infiltration anesthesia techniques administered using a computer-assisted anesthesia device (SleeperOne® 5; Dental HiTec, France) during restorative treatments of permanent first molars affected by Molar-Incisor Hypomineralization (MIH) in children. Clinical effectiveness will be evaluated based on the Visual Analogue Scale (VAS), behavioral pain response, pulse rate , salivary chromogranin A levels, and the need for additional anesthesia.

Eligibility 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: \-

Contact & Investigator

Central Contact

Gülsevim Oda, Assistant professor, pHD

✉ gulsevimoda@aybu.edu.tr

📞 90538948890

Principal Investigator

Ayşe I Cihan, Professor

STUDY CHAIR

Ankara Yıldırım Beyazit University Faculty of Dentistry

Frequently Asked Questions

Who can join the NCT07352813 clinical trial?

This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Molar Incisor Hypomineralization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07352813 currently recruiting?

Yes, NCT07352813 is actively recruiting participants. Contact the research team at gulsevimoda@aybu.edu.tr for enrollment information.

Where is the NCT07352813 trial being conducted?

This trial is being conducted at Ankara, Turkey (Türkiye).

Who is sponsoring the NCT07352813 clinical trial?

NCT07352813 is sponsored by Ankara Yildirim Beyazıt University. The principal investigator is Ayşe I Cihan, Professor at Ankara Yıldırım Beyazit University Faculty of Dentistry. The trial plans to enroll 30 participants.

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