RecruitingNot ApplicableNCT07352813

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

A Comparative Evaluation of the Clinical Effectiveness of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children With Molar-Incisor Hypomineralization


Sponsor

Ankara Yildirim Beyazıt University

Enrollment

30 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of dental anesthesia — injecting numbing medication directly into the bone (intraosseous) versus the traditional injection into the gum tissue (infiltration) — for children with a condition called Molar-Incisor Hypomineralization (MIH). MIH causes teeth to have weaker enamel that is often very sensitive and hard to numb with regular injections. **You may be eligible if:** - You are a child aged 6 to 12 years old - You are generally healthy with no known allergies - You have MIH affecting both upper first molars in a moderate to severe way - You score 3 or 4 on the Frankl Behavior Scale (meaning you are cooperative or very cooperative at the dentist) - You and your parent or guardian consent to participate - You have no urgent dental pain at the time of the study **You may NOT be eligible if:** - There are no specific exclusion criteria listed beyond not meeting the above requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntraosseous anaesthesia using a computerized system

Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.

PROCEDUREInfiltration anaesthesia using a computerized system

Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.


Locations(1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Turkey (Türkiye)

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NCT07352813


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