Buffered Versus Conventional Local Anesthesia for Pain and Anxiety Reduction in School-Aged Children With Pulpitis

Universidad Autonoma de San Luis Potosí60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulpitis

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) * Written informed consent provided by parent or legal guardian, and child assent when applicable * No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)

Secondary Outcomes

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)

Time frame: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)

Physiological indicators (Skin Conductance)

Description: Skin conductance will be measured using electrodermal activity (EDA) sensors during dental treatment. Unit of Measure: MicroSiemens (µS)

Time frame: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)

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

Time frame: Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)

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

Time frame: From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.

Duration of soft tissue anesthesia

Description: Time elapsed from confirmed loss of soft tissue sensation following local anesthetic administration until complete recovery of sensation as reported by the participant's caregiver. Unit of Measure: Minutes

Time frame: From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.