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

June 4, 2026 updated by: Daniela Guzmán Uribe, Universidad Autonoma de San Luis Potosí

Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78290
        • Recruiting
        • Universidad Autónoma de San Luis Potosí
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buffered Local Anesthesia
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
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.
Active Comparator: Conventional Local Anesthesia
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)
Standard commercially available local anesthetic solution used in routine dental practice without pH modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC PAIN SCORE
Time Frame: 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.
Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological indicators (Heart Rate)
Time Frame: 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)
Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Physiological indicators (Skin Conductance)
Time Frame: 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)
Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Wong-Baker Faces Pain Rating Scale Score
Time Frame: 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
Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Onset of local anesthesia
Time Frame: 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
From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.
Duration of soft tissue anesthesia
Time Frame: 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
From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-FE-041-025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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