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NCT Number: NCT07198997

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

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.

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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

digital anesthesia

Other

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

Primary outcomes

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

    Time frame: 6 month

Study contacts

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

PELİN T TURAN

CONTACT

[email protected]

+9 05517109013

ŞÜKRİYE T KAYACI

CONTACT

[email protected]

+9 05555109396

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

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.