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Completed

NCT Number: NCT07087028

Digital vs. Conventional Anesthesia for Primary Tooth Extractions in Pediatric Patients

This study aims to compare two different techniques of administering dental anesthesia to pediatric patients to determine which method causes less pain and anxiety during procedures like primary tooth extractions.

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Key information

Conditions

Pain Management Agnosia Dental Anesthesia Dental Anxiety Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatric Dentistry Perceptual Disorders Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, 35040, Turkey (Türkiye)

About this study

Dental anxiety, particularly in pediatric patients, is a significant challenge, often triggered by fear of local anesthesia injections. Although local anesthesia aims to prevent pain during treatment, the injection process itself can cause anxiety and defensive behaviors, especially in children. To address this, various methods have been introduced to reduce discomfort, including topical anesthetics, slow injections, and thinner needles. However, traditional methods still face challenges in regulating injection rates, leading to the development of computer-controlled local anesthetic delivery (CCLAD) systems.

CCLAD, particularly intraosseous anesthesia systems like SleeperOne™, offer a controlled flow rate and pressure during anesthesia delivery, potentially reducing discomfort and anxiety. Despite numerous studies, results on the effectiveness of CCLAD in pediatric patients remain controversial. This study aims to bridge this gap by comparing the efficacy of computerized intraosseous anesthesia with conventional infiltration anesthesia in pediatric patients undergoing primary molar extraction. The goal is to assess pain perception and anxiety levels, with the hypothesis that intraosseous anesthesia may lead to better outcomes in terms of pain and anxiety reduction compared to conventional techniques.

The use of the SleeperOne™ device for intraosseous anesthesia is hypothesized to be more effective in reducing pain and anxiety compared to conventional infiltration techniques during the extraction of primary molars in children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in between 6-12 years old
  • Physically and mentally healthy patients
  • Cooperative patients who were rated as positive or definitely positive according to the Frankl behavior classification scale
  • Patients who had primary molars that required extraction on both sides of maxillary arch.

Exclusion criteria

  • Children allergic to local anesthetics
  • Medically compromised and special children
  • Teeth with hypoplasia
  • Children who used analgesic drug 48 hours before treatment

Treatment and study plan

SleeperOne™

Device

Computerized intraosseous anesthesia was delivered using the SleeperOne™ (Dental HiTec, France) device with a 30 G × 9 mm Effitec needle at a 15° angle to the mucosa. A total of 2 mL 2% articaine with 1:100,000 epinephrine was administered per site.

Conventional Infiltration Anesthesia

Other

The intervention for the Conventional Infiltration Anesthesia involves the manual administration of a local anesthetic using a standard dental syringe with a fine-gauge needle.

Primary outcomes

  1. Pain Perception - Visual Analogue Scale

    Time frame: During anesthesia and during extraction in each visit.

    Pain was assessed using a 10-centimeter Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

  2. Pain Perception - Wong-Baker Faces Pain Rating Scale

    Time frame: During anesthesia and during extraction in each visit.

    Pain was assessed using the Wong-Baker Faces Pain Rating Scale (WBPRS), which ranges from 0 (no hurt) to 10 (hurts worst). Higher scores indicate worse pain.

  3. Dental Anxiety - State-Trait Anxiety Inventory for Children - State Subscale

    Time frame: At baseline, after anesthesia and after extraction in each visit.

    Dental anxiety was assessed using the short form of the State-Trait Anxiety Inventory for Children - State Subscale (STAI-S). Scores range from 10 (low anxiety) to 40 (high anxiety).

Secondary outcomes

  1. Physiological Arousal During Dental Procedure - Heart Rate

    Time frame: Before anesthesia, during anesthesia, and during extraction in each visit.

    Heart rate was measured using a pulse oximeter to monitor physiological arousal during the procedure. Heart rate may reflect a combination of pain, anxiety, and procedural stress. Unit of Measure is beats per minute (bpm). Higher values may indicate increased physiological arousal.

  2. Baseline Dental Anxiety Assessed by Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)

    Time frame: At the baseline before starting first visit.

    Baseline dental anxiety was assessed using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS), which includes 15 items scored from 1 to 5. Total scores range from 15 to 75. Higher scores indicate greater dental fear.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Comparison of Digital Anesthesia and Conventional Infiltration Techniques During Primary Tooth Extractions in Children

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 25, 2025
Registry last updated
Jul 25, 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.

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