The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
Children aged 6 to 12 years
Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
American Society of Anesthesiologists (ASA) Physical Status Classification I
Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
Known allergy to any component of local anesthetic solution
History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
Radiographic evidence of periapical pathology associated with the affected tooth
Presence of localized abscess or acute spreading infection at the injection site
Parallel
Buffered Lidocaine with Epinephrine
DrugLocal anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures.
idocaine with Epinephrine (Conventional)
DrugStandard commercially available local anesthetic solution used in routine dental practice without pH modification
FLACC PAIN SCORE
Pain behavior will be assessed using the FLACC(Face, Legs, Activity, Cry, and Consolability) Scale score, during different phases of dental treatment in children with pulpitis receiving local anesthesia. The scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain intensity and a worse outcome.
Physiological indicators (Heart Rate)
Description: Heart rate will be recorded using a blood volume pulse (BVP) sensor during dental treatment. Unit of Measure: Beats per minute (bpm)
Physiological indicators (Skin Conductance)
Description: Skin conductance will be measured using electrodermal activity (EDA) sensors during dental treatment. Unit of Measure: MicroSiemens (µS)
Wong-Baker Faces Pain Rating Scale Score
Self-reported pain whit Wong-Baker Faces Pain Rating Scale will be recorded at predefined clinical stages of treatment. Scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst pain possible
Onset of local anesthesia
Description: Time elapsed from completion of local anesthetic injection until confirmation of pulpal anesthesia. Pulpal anesthesia will be verified using cold testing (Endo Ice) after confirmation of soft tissue anesthesia. Unit of Measure: Minutes and seconds
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