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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07634900
Enrollment
128
Registered
2026-06-09
Start date
2026-04-01
Completion date
2027-03-20
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible, Pulpitis - Reversible

Keywords

Inferior alveolar nerve block, Digital anesthesia, Pediatric dentistry, Mandibular molar, Pain assessment

Brief summary

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.

Detailed description

Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety. Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia. The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars. Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales. In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess 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 results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.

Interventions

PROCEDUREComputer-Controlled Digital Anesthesia

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.

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.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be randomly assigned to one of two parallel groups: inferior alveolar nerve block (IANB) or computer-controlled digital anesthesia.

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* 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 * Patients whose parents/legal guardians provided informed consent

Exclusion criteria

* 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 * Patients with a history of behavioral management problems preventing treatment

Design outcomes

Primary

MeasureTime frameDescription
Anesthesia success during endodontic treatmentDuring the procedureAnesthetic 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.

Secondary

MeasureTime frameDescription
Heart rate changesBefore the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedureHeart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.

Countries

Turkey (Türkiye)

Contacts

CONTACTNisanur Müdüroğlu, DDS
nsnr_mdr@hotmail.com905434631893
CONTACTMerve Bilmez Selen, PhD
905457673098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026