Status:
COMPLETED
Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children
Lead Sponsor:
Ege University
Conditions:
Pain in Pediatric Dentistry
Dental Anxiety
Eligibility:
All Genders
6-12 years
Phase:
NA
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 trad...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06992193
Start Date
January 8 2025
End Date
April 1 2025
Last Update
May 28 2025
Active Locations (2)
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1
İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry
Istanbul, Turkey (Türkiye), 34500
2
Ege University Faculty of Dentistry Department of Pediatric Dentistry
Izmir, Turkey (Türkiye), 35100