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NCT Number: NCT07714915

Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

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.

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Key information

Conditions

Dental Anxiety Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pulpal Diseases Signs and Symptoms

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University

Merkez, Rize Province, 53020, Turkey (Türkiye)

Location contact

dilara nil günaçar

CONTACT

[email protected]

05412940104

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Dental Anxiety

    Time frame: Baseline and immediately after treatment

    Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.

  2. Behavioral Pain During Local Anesthesia

    Time frame: Immediately after local anesthetic injection

    Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.

Secondary outcomes

  1. Self-reported Pain

    Time frame: Immediately after local anesthetic injection

    Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment. Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

  2. Facial Image Scale (FIS) Score

    Time frame: Baseline and immediately after treatment.

    Emotional status assessed using the Facial Image Scale (FIS). Higher scores indicate greater anxiety. Emotional status assessed using the Facial Image Scale (FIS). The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face). Higher scores indicate greater anxiety.

  3. Heart Rate

    Time frame: Baseline and during local anesthetic administration

    Heart rate measured using a pulse oximeter.

  4. Blood Pressure

    Time frame: Baseline, during local anesthetic administration, and immediately after treatment

    Systolic and diastolic blood pressure measured with an automated monitor.

  5. Peripheral Oxygen Saturation (SpO₂)

    Time frame: Baseline, during local anesthetic administration, and immediately after treatment

    Peripheral oxygen saturation measured using pulse oximetry.

  6. Body Temperature

    Time frame: Baseline, during local anesthetic administration, and immediately after treatment

    Body temperature measured using a digital thermometer.

Study contacts

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

dilara nil günaçar

CONTACT

[email protected]

+905412940104

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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