An interventional study of Buffered Lidocaine with Epinephrine and idocaine with Epinephrine (Conventional) in Pulpitis, sponsored by Universidad Autonoma de San Luis Potosí. Recruiting at 1 site in Mexico. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Universidad Autonoma de San Luis Potosí · Not applicable, Interventional, and Treatment
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
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive buffered local anesthesia during dental treatment for pulpitis. The local anesthetic solution will consist of lidocaine with epinephrine combined with sodium bicarbonate to increase pH prior to administration. The intervention will be applied via local infiltration or nerve block as clinically indicated for pulpotomy or pulpectomy procedures in primary maxillary molars
Drug: Buffered Lidocaine with Epinephrine
Participants will receive conventional local anesthesia during dental treatment for pulpitis. The anesthetic solution will consist of lidocaine with epinephrine administered without buffering. The intervention will be applied via local infiltration or nerve block according to clinical indication for pulpotomy or pulpectomy procedures in primary maxillary molars.
Drug: idocaine with Epinephrine (Conventional)
Drug pages: Buffered Lidocaine · 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.
Standard 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.
Time frame: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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.
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Studies of the drugs tested here: Buffered Lidocaine · Epinephrine
Universidad Autonoma de San Luis Potosí