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Not yet recruiting NCT07714915

Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

No phase Interventional Dental Anxiety Pain Pulpal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer-Controlled Local Anesthesia, Conventional Inferior Alveolar Nerve Block, Articaine hydrochloride with epinephrine 1:100,000, Computer-Controlled Local Anesthetic Delivery System.
Who it may be relevant to
Registry conditions: Dental Anxiety, Pain, Pulpal Diseases. Basic parameters: 6 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial

Overview

This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.

Interventions

  • Procedure Computer-Controlled Local Anesthesia
    Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
  • Procedure Conventional Inferior Alveolar Nerve Block
    Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
  • Drug Articaine hydrochloride with epinephrine 1:100,000
    A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
  • Device Computer-Controlled Local Anesthetic Delivery System
    A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
  • Device Standard Dental Aspirating Syringe
    A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.

Primary outcome measures

  • Dental Anxiety [Time frame: Baseline and immediately after treatment]
  • Behavioral Pain During Local Anesthesia [Time frame: Immediately after local anesthetic injection]
Secondary outcome measures (6)
  • Self-reported Pain [Time frame: Immediately after local anesthetic injection]
  • Facial Image Scale (FIS) Score [Time frame: Baseline and immediately after treatment.]
  • Heart Rate [Time frame: Baseline and during local anesthetic administration]
  • Blood Pressure [Time frame: Baseline, during local anesthetic administration, and immediately after treatment]
  • Peripheral Oxygen Saturation (SpO₂) [Time frame: Baseline, during local anesthetic administration, and immediately after treatment]
  • Body Temperature [Time frame: Baseline, during local anesthetic administration, and immediately after treatment]

Eligibility criteria

Inclusion criteria

  • Children aged 6 to 8 years.
  • Requiring bilateral pulpectomy treatment of mandibular primary molars.
  • Frankl Behavior Rating Scale score of 3 or 4.
  • American Society of Anesthesiologists (ASA) Physical Status I.
  • No known allergy to local anesthetic agents.
  • No previous experience with dental local anesthesia.
  • No signs of acute abscess or swelling in the treatment area.
  • Parent or legal guardian able to provide written informed consent and child willing to participate.

Exclusion criteria

  • ASA Physical Status II or higher.
  • Known allergy or contraindication to local anesthetic agents.
  • Frankl Behavior Rating Scale score of 1 or 2.
  • Children receiving psychological or psychiatric treatment.
  • Physical or intellectual disabilities that could interfere with study procedures.
  • Previous experience with dental local anesthesia.
  • Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Recep Tayyip Erdoğan University — Merkez

Identifiers

NCT: NCT07714915 · 2026/268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗