Clinical trial NCT06992193: Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children
Official title: Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Paediatric Dentistry?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain in Pediatric Dentistry
Dental Anxiety
Keywords: Dental Anxiety
Pain Management
Intraosseous anesthesia
Local Anesthesia
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 79
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 to 12 years
* ASA I or II health status
* Cooperative behavior (Frankl score 3-4 or Venham score 0-2)
* Indicated for restorative, endodontic, or extraction treatment on primary teeth
* No prior local anesthesia experience during the previous 6 months

Exclusion Criteria:

* Presence of systemic or neurological diseases
* Use of analgesics within 48 hours before the procedure
* Uncooperative behavior (Frankl score 1-2 or Venham score \>2)
* Incomplete cooperation during the procedure
* Allergy to articaine, lidocaine, or epinephrine

Primary outcomes:
measure: Wong-Baker FACES pain scores at three time points
timeFrame: Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)
Secondary outcomes:
measure: Change in MCDAS anxiety scores before and after treatment
timeFrame: Day 1 - immediately before and after dental procedure
measure: FLACC behavioral pain scores during anesthesia
timeFrame: Periprocedural (Day 1) - during anesthetic injection phase
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry
city: İzmir
country: Turkey
facility: Ege University Faculty of Dentistry Department of Pediatric Dentistry
Study officials:
References: