Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Study ID
NCT07714915
Status
Not Yet Recruiting

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Conditions

  • Dental Anxiety
  • Pain
  • Pulpal Diseases

Eligibility Criteria

Sex
ALL
Age
6 Years - 8 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 9, 2026
Status verified
Jul 2026
Primary completion
Aug 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional Inferior Alveolar Nerve Block
  • Active Comparator: Computer-Controlled Local Anesthesia

Primary Outcome Measure

Dental Anxiety [ Time Frame: Baseline and immediately after treatment ]

Central Contacts

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