An interventional study of Intraosseous anaesthesia using a computerized system and Infiltration anaesthesia using a computerized system in Molar Incisor Hypomineralization and Hypersensitivity, sponsored by Ankara Yildirim Beyazıt University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
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.
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.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 30 is below the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Intraosseous anaesthesia using a computerized system
The infiltration anesthesia technique will be administered using the SleeperOne® 5 device and applied to the opposite side of the same patient.
Procedure: Infiltration anaesthesia using a computerized system
Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
Salivary Chromogranin A Levels
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.
Time frame: During dental treatment (Day 1): Baseline (before local anesthesia administration) Immediately after local anesthesia application Immediately after completion of the restorative procedure
Pulse Rate
Patients' heart rates will be measured using a pulse oximeter to assess physiological stress responses during dental treatment.
Time frame: During dental treatment (Day 1): • Baseline (before local anesthesia administration) • Immediately after local anesthesia application • Throughout the restorative treatment procedure
Visual Analogue Scale [VAS]
The Visual Analogue Scale (VAS) will be used to assess perceived pain intensity during dental treatment. VAS is a validated and widely used psychometric instrument for quantifying subjective pain experience on a 10-point scale, ranging from "No pain" to "Unbearable pain."
Time frame: During dental treatment (Day 1): Immediately after local anesthesia application Immediately after completion of the restorative procedure
Behavioral Pain Response (FLACC Score):
Behavioral pain response will be assessed using the FLACC scale, which consists of five behavioral categories: Face, Legs, Activity, Cry, and Consolability. Each category is scored from 0 to 2, yielding a total score ranging from 0 to 10. During the restorative procedure, video recordings will be obtained. An independent observer (E.Ü.A.), blinded to the anesthesia method, will evaluate the recordings and score the child's behavioral responses using the FLACC scale.
Time frame: TDuring dental treatment (Day 1): Throughout the restorative treatment procedure (single assessment)
Need for Additional Anesthesia
The adequacy of the administered anesthesia during dental treatment will be evaluated by the researcher. The requirement for additional anesthesia will be recorded as a dichotomous outcome (yes/no).
Time frame: During dental treatment (Day 1): Throughout the treatment procedure (single assessment)
Anesthesia Efficacy Assessment (Efficacy Scale):
Anesthesia efficacy will be assessed using an efficacy scale that evaluates the clinical success of the administered anesthesia based on the presence or absence of pain during the dental procedure. This scale reflects both the patient's pain experience and the clinician's ability to complete the planned treatment.
Time frame: Periprocedural (Day 1; immediately after completion of the restorative procedure)
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