RecruitingNot ApplicableNCT07524569

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial


Sponsor

Izmir Katip Celebi University

Enrollment

78 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

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Interventions

PROCEDUREIntraligamentary anaesthesia

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

PROCEDUREDigital Intraosseous Anesthesia

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


Locations(1)

Izmir Katip Çelebi University Faculty of Dentistry

Izmir, Cigli, Turkey (Türkiye)

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NCT07524569


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