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

NCT07198997 | Not Yet Recruiting

• 1 other identifier: SPZ001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

anxiety reduction, CCLA, digital anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale

  6 month

Study Arms (2)

Digital intraosseous anesthesia

EXPERIMENTAL

Other: digital anesthesia

conventional mandibular nerve block anesthesia.

ACTIVE COMPARATOR

Other: digital anesthesia

Interventions

digital anesthesia OTHER

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

Digital intraosseous anesthesia; conventional mandibular nerve block anesthesia.

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Study Officials

• ŞÜKRİYE T KAYACI

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Central Study Contacts

PELİN T TURAN

CONTACT

+9 05517109013; pelintturan@gmail.com

ŞÜKRİYE T KAYACI

CONTACT

+9 05555109396; sukriyeturkoglu1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

TU (1)