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Clinical Trials in Turkey / NCT07524569
Recruiting Not applicable

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

NCT07524569 · tracked via the Priya Life Science Turkey tracker
Sponsor
Izmir Katip Celebi University
Phase
Not applicable
Started
2026-04-01
Last updated
2026-04-13

Condition(s) studied

AnesthesiaLocal

Investigational drug(s) / intervention(s)

Intraligamentary anaesthesiaDigital Intraosseous Anesthesia

Intraligamentary anaesthesia: Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

Digital Intraosseous Anesthesia: Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

Study summary

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Subjects with American Society of Anesthesiologists score I (ASA I) * Subjects with Frankl's behavior rate III (positive) and IV (definitely positive), * Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars * Subjects whose plaque index score of 0 (no plaque) and 1 * Subjects whose gingival index score of 0 Exclusion Criteria: * Allergic to the local anesthetics or sulfites * Subjects with cholinesterase deficiency * Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents * Subjects who need to use sedatives or other medications during dental procedures

Primary outcome measure(s)

  • Pain intensity using Visual Analog Scale (VAS) — During injection and during dental procedure
    Subjective pain perception measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst possible pain). Pain is assessed during injection and during dental treatment.
  • Pain intensity using Wong-Baker FACES Pain Rating Scale — During injection and during dental procedure
    Subjective pain perception measured using the Wong-Baker FACES Pain Rating Scale (0-10), where higher scores indicate greater pain. Pain is assessed during injection and during dental treatment.
  • Heart rate changes — Baseline, during injection and during dental procedure
    Heart rate measured using a pulse oximeter (beats per minute, bpm).
  • Oxygen saturation (SpO₂) changes — Baseline, during injection and during dental procedure
    Arterial oxygen saturation measured using a pulse oximeter (%).
  • Practitioner's assessment of anesthesia success — Immediately after dental treatment
    Clinician-reported outcomes including need for additional anesthesia, presence of discomfort during treatment, and successful completion of the procedure without pain.
  • Postoperative complications — Day 1 after intervention
    Presence of postoperative complications related to local anesthesia.

Trial sites (1)

FacilityCityRegionStatus
Izmir Katip Çelebi University Faculty of Dentistry Izmir Cigli Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524569 on ClinicalTrials.gov ↗ ← All trials in Turkey