Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children

Not Applicable

Completed

• Conditions: Pain in Pediatric Dentistry; Dental Anxiety
• Interventions: Device: Digital Anesthesia; Drug: Infiltration Anesthesia; Drug: Mandibular Block

• Registration Number: NCT06992193
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2025-01-08
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Anesthesia	Digital Anesthesia	Children receiving intraosseous local anesthesia via a computer-controlled delivery system (SleeperOne 5®) using 4% articaine with 1:200,000 epinephrine.
Infiltration Anesthesia	Infiltration Anesthesia	Children receiving traditional infiltration anesthesia using 2% lidocaine with 1:100,000 epinephrine via standard dental syringe.
Mandibular Block Anesthesia	Mandibular Block	Children receiving conventional inferior alveolar nerve block with 2% lidocaine and 1:100,000 epinephrine using a long dental needle.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES pain scores at three time points	Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)	Pain was assessed using the Wong-Baker FACES Pain Rating Scale at three stages: (1) needle insertion, (2) anesthetic delivery, and (3) during dental treatment. Scores range from 0 (no hurt) to 10 (hurts worst).

Secondary Outcome Measures

Name	Time	Method
Change in MCDAS anxiety scores before and after treatment	Day 1 - immediately before and after dental procedure	Dental anxiety was measured using the Modified Child Dental Anxiety Scale (MCDAS) immediately before and after the procedure. The scale ranges from 8 to 40, with higher scores indicating greater anxiety.
FLACC behavioral pain scores during anesthesia	Periprocedural (Day 1) - during anesthetic injection phase	Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.

Trial Locations

Locations (2)

İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry; 🇹🇷 İstanbul, Turkey

Ege University Faculty of Dentistry Department of Pediatric Dentistry; 🇹🇷 İzmir, Turkey