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MIHComparative Evaluation of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children with Molar-Incisor Hypomineralization

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Study Aim

This study aims to compare the stress levels, measured through salivary Chromogranin A levels, in children with Molar-Incisor Hypomineralization undergoing dental treatment using either computer-assisted intraosseous or infiltration anesthesia techniques.

What is being tested

Intraosseous anaesthesia using a computerized system

+ Infiltration anaesthesia using a computerized system

Procedure
Who is being recruted

Congenital Abnormalities+14

+ Developmental Defects of Enamel

+ Dental Enamel Hypomineralization

From 6 to 12 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorAnkara Yildirim Beyazıt University
Study ContactGülsevim Oda, Assistant professor, pHDMore contacts
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 7, 2025

Actual date on which the first participant was enrolled.

This research focuses on children with Molar-Incisor Hypomineralization (MIH), a condition that affects the enamel of molars and incisors, making them more prone to cavities. The study aims to find a minimally invasive and effective way to administer anesthesia for these children during dental treatments. It includes children aged 6 to 12 years who have MIH and cavities not reaching the pulp in their upper permanent first molars. The study is important as it addresses the challenge of managing pain in children with MIH, a condition known to respond differently to anesthesia due to enamel changes. The study involves three sessions. In the first session, a detailed medical and dental history is taken, and the degree of MIH and cavities are evaluated. No invasive procedures are performed in this session. In the second and third sessions, two different anesthesia methods are applied to the upper right and left first permanent molars, respectively. The order of anesthesia methods is determined by randomization. During these sessions, the child's pain level, pulse rate, and saliva samples are collected at various stages. The saliva samples are used to measure stress levels. The child's behavior during treatment is also recorded for evaluation. The study's outcome will help in understanding which anesthesia method is more effective and less stressful for children with MIH.

Official TitleA Comparative Evaluation of the Clinical Effectiveness of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children With Molar-Incisor Hypomineralization 
Principal SponsorAnkara Yildirim Beyazıt University
Study ContactGülsevim Oda, Assistant professor, pHDMore contacts
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesDevelopmental Defects of EnamelDental Enamel HypomineralizationMolar HypomineralizationFacial PainHypersensitivityImmune System DiseasesStomatognathic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsTooth AbnormalitiesTooth DiseasesToothacheStomatognathic System Abnormalities

Criteria

8 inclusion criteria required to participate
Individuals without any known allergies

Children between the ages of 6 and 12 years

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

Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry

Show More Criteria

1 exclusion criteria prevent from participating
Children with no emergency treatment needs, such as dental pain

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intraosseous anesthesia technique will be administered using the computer-assisted anesthesia device (SleeperOne® 5) and applied to either the right or left upper permanent molar, assigned at random.

Group II

Active Comparator
The infiltration anesthesia technique will be administered using the SleeperOne® 5 device and applied to the opposite side of the same patient.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Turkey (Türkiye)See the location
Recruiting
One Study Center