Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraligamentary anaesthesia, Digital Intraosseous Anesthesia.
- Who it may be relevant to
- Registry conditions: Anesthesia, Local. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
Overview
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.
Detailed description
Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.
The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.
Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.
Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.
Interventions
- Procedure Intraligamentary anaesthesia
Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection - Procedure Digital Intraosseous Anesthesia
Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone
Primary outcome measures
- Pain intensity using Visual Analog Scale (VAS) [Time frame: During injection and during dental procedure]
- Pain intensity using Wong-Baker FACES Pain Rating Scale [Time frame: During injection and during dental procedure]
- Heart rate changes [Time frame: Baseline, during injection and during dental procedure]
- Oxygen saturation (SpO₂) changes [Time frame: Baseline, during injection and during dental procedure]
- Practitioner's assessment of anesthesia success [Time frame: Immediately after dental treatment]
- Postoperative complications [Time frame: Day 1 after intervention]
Secondary outcome measures (1)
- Correlation between pain scores measured by VAS and Wong-Baker FACES scale [Time frame: Immediately after injection]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Izmir Katip Çelebi University Faculty of Dentistry — Izmir
Identifiers
NCT: NCT07524569 · 2025/75