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

NCT07634900 | Recruiting

• 1 other identifier: 2025/8393
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible; Pulpitis - Reversible

Keywords

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

Outcome Measures

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.

  During the procedure

Secondary Outcomes (1)

• Heart rate changes

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

Other Outcomes (1)

• Blood pressure changes

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

Study Arms (2)

Inferior Alveolar Nerve Block Group

EXPERIMENTAL

Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.

Procedure: Inferior Alveolar Nerve Block

Digital Anesthesia Group

EXPERIMENTAL

Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.

Procedure: Computer-Controlled Digital Anesthesia

Interventions

Computer-Controlled Digital Anesthesia PROCEDURE

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.

Digital Anesthesia Group

Inferior Alveolar Nerve Block PROCEDURE

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.

Inferior Alveolar Nerve Block Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, Malatya, 44280, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.

  PMID: 37209243 RESULT

Central Study Contacts

Nisanur Müdüroğlu, DDS

CONTACT

905434631893; nsnr_mdr@hotmail.com

Merve Bilmez Selen, PhD

CONTACT

905457673098

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Pediatric Dentistry, Inonu University

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

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)