Comparison of the Effects of Intraosseous Anesthesia Performed With the SleeperOne5 Computer-Controlled Device and Conventional Mandibular Nerve Block on Behavior and Pain Control During Anesthesia Administration in Children Aged 5-9

Not Applicable

Not yet recruiting

• Conditions: the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological Parameters

• Registration Number: NCT07198997
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

The injection stage is the most intense cause of anxiety during dental treatment in the pediatric patient group. It is aimed to keep the pain sensation at a minimum during this process. Computer-controlled local anesthesia delivery systems that can inject anesthetic solution at a fixed rate, pressure and volume have been developed in order to reduce pain, discomfort, anxiety and control the injection flow. This study aimed to compare the behavioral and physiological differences in children between the computer-controlled intraosseous anesthesia technique and conventional inferior alveolar nerve blockade. 100 systemically healthy children aged 6-9 years with contralateral pulpotomy or pulpectomy of the mandible and the 2nd primary molar tooth will be included in this study. During the application of local anesthesia, heart rate, which is a physiological criterion, will be measured in the assessment of pain. For this purpose, fingertip pulse oximeter will be used. The child's cooperation level during the treatment process will be evaluated using the Venham behavioral rating scale. The "visual analog scale" will be shared with the patients and the pain perception during the treatment process will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Study Start: 2025-10-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• One hundred systemically healthy children aged 6 to 9 years, with Frankl Behavior Scale scores of 3 and 4, who have not used any analgesics within 48 hours prior to the study.

Exclusion Criteria

• Children with teeth exhibiting mobility, necrosis, furcation involvement, or periapical radiolucency, and children who do not have contralateral second primary molars in different quadrants of the mandible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale	6 month

Trial Locations

Locations (1)

University of Health Sciences; Istanbul, Turkey (Türkiye)