Pulpitis
Conditions
Keywords
Anesthesia, Dental, Anesthesia, Local, Buffers
Brief summary
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
Interventions
DRUGBuffered Lidocaine with Epinephrine
Local anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures.
DRUGidocaine with Epinephrine (Conventional)
Standard commercially available local anesthetic solution used in routine dental practice without pH modification
Sponsors
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, the treating clinician, and the outcome assessors will be blinded to group allocation. Allocation concealment will be ensured using a block randomization method. Group assignment will be coded as Group A and Group B, and concealed in sealed, opaque containers until the end of data analysis.
Intervention model description
Participants will receive one of two interventions during routine dental treatment: buffered local anesthesia or conventional local anesthesia. Clinical procedures may include pulpotomy or pulpectomy depending on diagnosis. Pain, anxiety, and anesthetic efficacy outcomes will be assessed during different phases of treatment.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC PAIN SCORE | Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological indicators (Heart Rate) | Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) | 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) | Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) | 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 | Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) | 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 | From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit. | 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 |
| Duration of soft tissue anesthesia | From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment. | 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 |
Countries
Mexico
Contacts
CONTACTMayte A Condori Chambi, Cirujano Dentista
Outcome results
None listed