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MIH

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

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What is being tested

Intraosseous anaesthesia using a computerized system

+ Infiltration anaesthesia using a computerized system
Procedure
Who is being recruted

Congenital Abnormalities
+14

+ Facial Pain
+ Hypersensitivity
From 6 to 12 Years
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, 2025Actual date on which the first participant was enrolled.

Children who present to the Pediatric Dentistry Clinic of Ankara Yıldırım Beyazıt University, Dental Research and Application Center, and are deemed eligible for inclusion in the study based on routine clinical examination and radiographic evaluation, will be provided with written and verbal information regarding the purpose and scope of the research. Informed consent will be obtained from those children and their legal guardians who voluntarily agree to participate in the study. The study plans to include 30 children aged between 6 and 12 years, who have no systemic diseases and present with Molar-Incisor Hypomineralization (MIH) and carious lesions not extending to the pulp tissue in their maxillary permanent first molars. A three-session treatment protocol will be administered to participants who meet the inclusion criteria and have signed the informed consent form. A minimum interval of one week will be maintained between sessions, and the sequence of interventions will be determined through randomization. First Session: In the first session, a detailed medical and dental history of the patient will be obtained. During the intraoral examination, teeth affected by MIH will be identified, and the degree of MIH as well as the presence of carious lesions will be evaluated through clinical and radiographic examination. All findings will be recorded in the patient data form. In this session, no invasive procedures will be performed. The materials and methods to be used will be explained to the patient, and the Frankl Behavior Rating Scale will be applied to determine the preoperative anxiety level, serving as an acclimatization session. Second Session: The anesthesia method to be applied to the patient's upper right first permanent molar (tooth no. 16) in the second session will be determined using a randomization method. Before the administration of anesthesia, the technique of the procedure will be explained verbally to the pediatric patient; the first saliva sample will be collected, and pulse rate values will be measured and recorded using a pulse oximeter. The anesthesia method determined by randomization will be applied to tooth number 16. During anesthesia administration, the patient will be asked to evaluate the pain level experienced using the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain). After anesthesia, the pulse rate will again be recorded, and the second saliva sample will be collected. The carious tissue of the affected tooth will be removed using a high-speed and low-speed handpiece. At this stage, the heart rate will also be measured and recorded using the pulse oximeter. At the end of the treatment, the third saliva sample will be collected, and the patient will be asked to evaluate the pain level experienced using the VAS. Saliva samples as well as immediately after treatment completion and stored at -20 °C until biochemical analysis. Throughout the treatment, the patient's behavioral responses will be video recorded and objectively evaluated by an independent observer, blinded to the anesthesia method, using the FLACC scale. The need for additional anesthesia and the efficacy of the anesthesia will be assessed after treatment. Third Session: In the third session, the anesthesia technique will be changed, and anesthesia will be administered to the contralateral first molar tooth (in the symmetrical arch) with the same indication. The procedures performed in the second session will be repeated. At the conclusion of this study, the comparison of anesthesia techniques used in the treatment of MIH-affected teeth in children will enable the identification of a minimally invasive and effective approach to anesthesia. It is well established that teeth affected by MIH exhibit an altered response to anesthesia due to hypersensitivity and structural changes in the enamel. This study aims to contribute to the existing gap in the scientific literature on this topic. The comparative evaluation of computer-assisted intraosseous and infiltration anesthesia techniques will facilitate evidence-based decision-making in clinical practice.

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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 6 to 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Congenital Abnormalities
Facial Pain
Hypersensitivity
Immune System Diseases
Stomatognathic Diseases
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Neurologic Manifestations
Pain
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Tooth Abnormalities
Tooth Diseases
Toothache
Stomatognathic System Abnormalities
Developmental Defects of Enamel
Dental Enamel Hypomineralization
Molar Hypomineralization
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: \-


Study Plan

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

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

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

To objectively assess the stress levels experienced by children during dental treatment, changes in salivary chromogranin A concentrations will be measured at predefined time points during the procedure.

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 DentistryAnkara, Turkey (Türkiye)See the location

Recruiting
One Study Center