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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-04-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Digital intraosseous anesthesia

Group Type EXPERIMENTAL

digital anesthesia

Intervention Type OTHER

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

conventional mandibular nerve block anesthesia.

Group Type ACTIVE_COMPARATOR

digital anesthesia

Intervention Type OTHER

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

Interventions

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digital anesthesia

mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No