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

Ege University

Status: Completed

Conditions: Dental Anxiety; Pain in Pediatric Dentistry

Treatments: Drug: Mandibular Block; Drug: Infiltration Anesthesia; Device: Digital Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06992193

Alp

24-11/83 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 3 patient groups

Digital Anesthesia

Experimental group

Description:

Children receiving intraosseous local anesthesia via a computer-controlled delivery system (SleeperOne 5®) using 4% articaine with 1:200,000 epinephrine.

Treatment:

Device: Digital Anesthesia

Infiltration Anesthesia

Active Comparator group

Description:

Children receiving traditional infiltration anesthesia using 2% lidocaine with 1:100,000 epinephrine via standard dental syringe.

Treatment:

Drug: Infiltration Anesthesia

Mandibular Block Anesthesia

Active Comparator group

Description:

Children receiving conventional inferior alveolar nerve block with 2% lidocaine and 1:100,000 epinephrine using a long dental needle.

Treatment:

Drug: Mandibular Block