Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorIzmir Katip Celebi University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Intraligamentary anaesthesia
Procedure/SurgeryAnesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection
Digital Intraosseous Anesthesia
Procedure/SurgeryAnesthesia for one tooth using computer-controlled single-point injection into cancellous bone
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Intraligamentary AnaesthesiaExperimental treatment 1 intervention
Group B: Digital Intraosseous AnesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity using Visual Analog Scale (VAS)
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.
Time frame
During injection and during dental procedure2
Pain intensity using Wong-Baker FACES Pain Rating Scale
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.
Time frame
During injection and during dental procedure3
Heart rate changes
Heart rate measured using a pulse oximeter (beats per minute, bpm).
Time frame
Baseline, during injection and during dental procedure4
Oxygen saturation (SpO₂) changes
Arterial oxygen saturation measured using a pulse oximeter (%).
Time frame
Baseline, during injection and during dental procedureSecondary outcomes
1
Correlation between pain scores measured by VAS and Wong-Baker FACES scale
Correlation between pain scores measured using the Visual Analog Scale (VAS, 0-10) and Wong-Baker FACES Pain Rating Scale (0-10) following local anesthetic injection in children aged 6-12 years. Higher scores indicate greater pain intensity.
Time frame
Immediately after injectionSponsors and contacts
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Source ClinicalTrials.gov