Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorAnkara Yildirim Beyazıt University
About this trial
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
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Intraosseous anaesthesia using a computerized system
Procedure/SurgeryArticaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
Infiltration anaesthesia using a computerized system
Procedure/SurgeryArticaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intraosseous AnesthesiaExperimental treatment 1 intervention
Group B: Infiltration AnesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
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 procedure2
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 procedure3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov