Actively Recruiting
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
Led by Izmir Katip Celebi University · Updated on 2026-04-13
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two anesthesia methods—digital intraosseous anesthesia and manual intraligamentary anesthesia—to see how they affect pain during dental treatment on permanent lower molars in children aged 6 to 12 years. The study will examine pain levels during injection and treatment, success of anesthesia, any side effects afterward, and which method children prefer. This is a randomized, controlled, crossover, single-blind study involving 78 children with specific dental conditions. Participants will be divided into two groups receiving anesthesia in different sequences with a one-week break between visits. One group will first receive the manual intraligamentary anesthesia and then the digital intraosseous anesthesia, while the other group will receive the treatments in reverse order. The manual method involves injecting articaine solution slowly into the periodontal sulcus with a special needle and injector. The digital method uses a computer-controlled device to deliver anesthesia precisely into the bone near the tooth. Children's pain will be measured using visual scales during both injections and dental procedures, and their heart rate and oxygen levels will be monitored. Anesthesia success will be assessed right after treatment, and any complications will be tracked by contacting participants one day after each visit. After the second visit, children will be asked which anesthesia method they liked better. The study will end in October 2027.
CONDITIONS
Brief Title
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive two different anesthesia techniques applied to their mandibular first molars in two separate visits with a one-week washout period between visits. Pain perception and physiological parameters are monitored during both anesthesia administrations and dental procedures.
2 visits (in-person) with a 1-week interval
Duration - 2 days
Participants are contacted one day after each anesthesia visit to document any postoperative complications and to record their preferred anesthesia technique at the end of the second visit.
2 phone contacts (1 day after each treatment visit)
Trial Site Locations
Total: 1 location
1
Izmir Katip Çelebi University Faculty of Dentistry
Izmir, Cigli, Turkey (Türkiye), 35000
Actively Recruiting
Research Team
F
Funda Çağırır Dindaroğlu, Study Director
B
Buse Düzgün, Principal Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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