Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorInonu University

About this trial

This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.

Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.

The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 6-14 years

Patients presenting with acute dental pain

Patients requiring emergency endodontic treatment in mandibular permanent molars

Cooperative patients who allowed clinical procedures

Disqualifiers

Patients with systemic diseases affecting pain perception

Patients with known allergy to local anesthetic agents

Patients who used analgesics within 12 hours before treatment

Patients with non-restorable teeth

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computer-Controlled Digital Anesthesia

    Procedure/Surgery

    Participants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine.

  • Inferior Alveolar Nerve Block

    Procedure/Surgery

    Participants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Inferior Alveolar Nerve Block GroupExperimental treatment 1 intervention
Group B: Digital Anesthesia GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anesthesia success during endodontic treatment

Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia. Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success. Higher VAS scores indicate greater pain perception and lower anesthetic success.

Time frame
During the procedure

Secondary outcomes

1

Heart rate changes

Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.

Time frame
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure

Other outcomes

1

Blood pressure changes

Blood pressure will be measured at predefined time points to assess the physiological stress response associated with the anesthesia techniques.

Time frame
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.