NCT07524569

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Detailed description

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits. The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit. Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure. Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

Conditions

• Anesthesia
• Local

Interventions

Type	Name	Description
PROCEDURE	Intraligamentary anaesthesia	Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection
PROCEDURE	Digital Intraosseous Anesthesia	Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)