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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

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: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07198997
Enrollment
100
Registered
2025-09-30
Start date
2025-10-01
Completion date
2026-04-01
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

anxiety reduction, CCLA, digital anesthesia

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.

Interventions

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale6 month

Countries

Turkey (Türkiye)

Contacts

Primary ContactPELİN T TURAN
pelintturan@gmail.com+9 05517109013
Backup ContactŞÜKRİYE T KAYACI
sukriyeturkoglu1@gmail.com+9 05555109396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026