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

NCT07638254 | Recruiting DMC

• 1 other identifier: CEI-FE-041-025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pulpitis

Keywords

Anesthesia, Dental; Anesthesia, Local; Buffers

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• Physiological indicators (Heart Rate)

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

• Physiological indicators (Skin Conductance)

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

• 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)

• Onset of local anesthesia

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

• 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.

Study Arms (2)

Buffered Local Anesthesia

EXPERIMENTAL

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

Conventional Local Anesthesia

ACTIVE COMPARATOR

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)

Interventions

Buffered Lidocaine with Epinephrine DRUG

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.

Buffered Local Anesthesia

idocaine with Epinephrine (Conventional) DRUG

Standard commercially available local anesthetic solution used in routine dental practice without pH modification

Conventional Local Anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, 78290, Mexico

RECRUITING

Related Publications (2)

• Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21.

  PMID: 29377171 BACKGROUND

• Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.

  PMID: 30087760 BACKGROUND

MeSH Terms

Conditions

Pulpitis

Interventions

Epinephrine; Congresses as Topic

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organizations; Health Care Economics and Organizations

Central Study Contacts

Mayte A Condori Chambi, Cirujano Dentista

CONTACT

+524446641295; maytecondori97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 10, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

ME (1)