This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
Recep Tayyip Erdoğan University
Merkez, Rize Province, Turkey (Türkiye)
Dental Anxiety
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
Time frame: Baseline and immediately after treatment
Behavioral Pain During Local Anesthesia
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.
Time frame: Immediately after local anesthetic injection
Self-reported Pain
Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment. Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: Immediately after local anesthetic injection
Facial Image Scale (FIS) Score
Emotional status assessed using the Facial Image Scale (FIS). Higher scores indicate greater anxiety. Emotional status assessed using the Facial Image Scale (FIS). The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face). Higher scores indicate greater anxiety.
Time frame: Baseline and immediately after treatment.
Heart Rate
Heart rate measured using a pulse oximeter.
Time frame: Baseline and during local anesthetic administration
Blood Pressure
Systolic and diastolic blood pressure measured with an automated monitor.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured using pulse oximetry.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
Body Temperature
Body temperature measured using a digital thermometer.
Time frame: Baseline, during local anesthetic administration, and immediately after treatment
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