Anesthesia, Local
Conditions
Keywords
intraligamentary anesthesia, paediatric dentistry, Digital Intraosseous Anesthesia
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.
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
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization was performed by a computer-generated random sorting sequence
Intervention model description
Randomized controlled, single-blind, split-mouth clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity using Visual Analog Scale (VAS) | 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 | 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 | Baseline, during injection and during dental procedure | Heart rate measured using a pulse oximeter (beats per minute, bpm). |
| Oxygen saturation (SpO₂) changes | Baseline, during injection and during dental procedure | Arterial oxygen saturation measured using a pulse oximeter (%). |
| Practitioner's assessment of anesthesia success | 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 | Day 1 after intervention | Presence of postoperative complications related to local anesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between pain scores measured by VAS and Wong-Baker FACES scale | Immediately after injection | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFunda Çağırır Dindaroğlu, Study Director
CONTACTBuse Düzgün, Principal Investigator
Outcome results
None listed