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NCT Number: NCT07634900

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

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Faculty of Dentistry

Malatya, 44280, Turkey (Türkiye)

Location status: Recruiting

Location contact

nisanur müdüroğlu

CONTACT

[email protected]

905434631893

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Anesthesia success during endodontic treatment

    Time frame: During the procedure

    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.

Secondary outcomes

  1. Heart rate changes

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

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

Other outcomes

  1. Blood pressure changes

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

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

Study contacts

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

Merve Bilmez Selen, PhD

CONTACT

905457673098

Nisanur Müdüroğlu, DDS

CONTACT

[email protected]

905434631893

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 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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