Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorRecep Tayyip Erdogan University Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Computer-Controlled Local Anesthesia

    Procedure/Surgery

    Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.

  • Conventional Inferior Alveolar Nerve Block

    Procedure/Surgery

    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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Conventional Inferior Alveolar Nerve BlockActive comparator 3 interventions
Group B: Computer-Controlled Local AnesthesiaActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Dental Anxiety

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

Time frame
Baseline and immediately after treatment
2

Behavioral Pain During Local Anesthesia

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.

Time frame
Immediately after local anesthetic injection

Secondary outcomes

1

Self-reported Pain

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.

Time frame
Immediately after local anesthetic injection
2

Facial Image Scale (FIS) Score

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.

Time frame
Baseline and immediately after treatment.
3

Heart Rate

Heart rate measured using a pulse oximeter.

Time frame
Baseline and during local anesthetic administration
4

Blood Pressure

Systolic and diastolic blood pressure measured with an automated monitor.

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Recep Tayyip Erdoğan University Status unavailable 53020, Merkez, Rize ProvinceTurkey (Türkiye)

Sponsors and contacts

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