Izmir Katip Çelebi University Faculty of Dentistry
Izmir, Cigli, 35000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07524569
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.
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Izmir, Cigli, 35000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection
Other names: 2 or 4 points intraligamentary injection
Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone
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.
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.
Time frame: Baseline, during injection and during dental procedure
Heart rate measured using a pulse oximeter (beats per minute, bpm).
Time frame: Baseline, during injection and during dental procedure
Arterial oxygen saturation measured using a pulse oximeter (%).
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.
Time frame: Day 1 after intervention
Presence of postoperative complications related to local anesthesia.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Buse Düzgün, Principal Investigator
CONTACT
Funda Çağırır Dindaroğlu, Study Director
CONTACT
Izmir Katip Celebi University
Other
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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