Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Pain intensity using Visual Analog Scale (VAS)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Randomization was performed by a computer-generated random sorting sequence
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intraligamentary Anaesthesia
Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.
Intervention: Intraligamentary anaesthesia (Procedure)
Digital Intraosseous Anesthesia
For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth.
To maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.
Intervention: Digital Intraosseous Anesthesia (Procedure)
Outcomes
Primary Outcomes
Pain intensity using Visual Analog Scale (VAS)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, during injection and during dental procedure
Heart rate measured using a pulse oximeter (beats per minute, bpm).
Oxygen saturation (SpO₂) changes
Time Frame: Baseline, during injection and during dental procedure
Arterial oxygen saturation measured using a pulse oximeter (%).
Practitioner's assessment of anesthesia success
Time Frame: 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
Time Frame: Day 1 after intervention
Presence of postoperative complications related to local anesthesia.
Secondary Outcomes
- Correlation between pain scores measured by VAS and Wong-Baker FACES scale(Immediately after injection)
Investigators
Funda Cagırır Dindaroglu
Assoc. Prof. Dr.
Izmir Katip Celebi University