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Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Paediatric Dentistry?
This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients. A total of 79 children aged 6-12 years were randomly assigned to one of three groups. Pain perception, anxiety levels, and behavioral responses were assessed using validated tools including the Wong-Baker FACES Pain Scale, the Modified Child Dental Anxiety Scale (MCDAS), and the FLACC behavioral scale. The study aimed to determine whether digital anesthesia could provide a less painful and less anxiety-inducing experience for children during dental treatment. Findings may support broader clinical adoption of computer-assisted anesthetic delivery in paediatric dentistry.
This randomized controlled clinical trial was designed to compare the effects of digital anesthesia, conventional infiltration, and mandibular block techniques on pain perception, anxiety levels, and behavioral responses in paediatric dental patients. The study was conducted at two academic institutions: Ege University and Beykent University in Turkey. A total of 79 healthy, cooperative children aged 6 to 12 years requiring restorative, endodontic, or extraction procedures on primary teeth were randomly assigned to one of three anesthesia groups: digital anesthesia (n=34), infiltration (n=22), and mandibular block (n=23). Randomization was performed using a computer-generated sequence, and pain, anxiety, and behavior were assessed by a blinded, calibrated examiner. The digital anesthesia group received intraosseous injection via the SleeperOne 5® system (using 4% articaine with 1:200,000 epinephrine). The infiltration and block groups received 2% lidocaine with 1:100,000 epinephrine using conventional syringes. All patients received topical 20% benzocaine gel prior to injection. Pain was assessed at three time points (needle insertion, anesthetic delivery, and treatment) using the Wong-Baker FACES scale. Dental anxiety was measured pre- and post-treatment using the Modified Child Dental Anxiety Scale (MCDAS), and behavioral responses were recorded during treatment using the FLACC scale. The aim was to evaluate whether digital anesthesia provides superior outcomes in terms of comfort, reduced fear, and improved cooperation in the paediatric dental setting.
Age
6 - 12 years
Sex
ALL
Healthy Volunteers
Yes
İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry
Istanbul, Turkey (Türkiye)
Ege University Faculty of Dentistry Department of Pediatric Dentistry
Izmir, Turkey (Türkiye)
Start Date
January 8, 2025
Primary Completion Date
April 1, 2025
Completion Date
April 1, 2025
Last Updated
May 28, 2025
79
ACTUAL participants
Digital Anesthesia
DEVICE
Infiltration Anesthesia
DRUG
Mandibular Block
DRUG
Lead Sponsor
Ege University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06434844