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NCT Number: NCT07638254

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

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

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Key information

Conditions

Pulpitis Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de San Luis Potosí

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

Location status: Recruiting

Location contact

Mayte A Condori Chambi, Cirujano Dentista

CONTACT

[email protected]

4446641295

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

idocaine with Epinephrine (Conventional)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mayte A Condori Chambi, Cirujano Dentista

CONTACT

[email protected]

+524446641295

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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