About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 6 to 8 years.
Requiring bilateral pulpectomy treatment of mandibular primary molars.
Frankl Behavior Rating Scale score of 3 or 4.
American Society of Anesthesiologists (ASA) Physical Status I.
Disqualifiers
ASA Physical Status II or higher.
Known allergy or contraindication to local anesthetic agents.
Frankl Behavior Rating Scale score of 1 or 2.
Children receiving psychological or psychiatric treatment.
Trial design
Crossover
Treatments tested in this trial
Computer-Controlled Local Anesthesia
Procedure/SurgeryComputer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
Conventional Inferior Alveolar Nerve Block
Procedure/SurgeryConventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
Articaine hydrochloride with epinephrine 1:100,000
DrugA 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
Computer-Controlled Local Anesthetic Delivery System
DeviceA computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
Standard Dental Aspirating Syringe
DeviceA conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
Treatment groups
Trial outcomes
Primary outcomes
Dental Anxiety
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
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.
Secondary outcomes
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.
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.
Heart Rate
Heart rate measured using a pulse oximeter.
Blood Pressure
Systolic and diastolic blood pressure measured with an automated monitor.
Locations
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Sponsors and contacts
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