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

NCT06992193 | Completed

• 2 other identifiers: Alp24-11/83
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain in Pediatric Dentistry; Dental Anxiety

Keywords

Dental Anxiety; Pain Management; Intraosseous anesthesia; Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Wong-Baker FACES pain scores at three time points

  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).

  Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)

Secondary Outcomes (2)

• Change in MCDAS anxiety scores before and after treatment

  Day 1 - immediately before and after dental procedure

• FLACC behavioral pain scores during anesthesia

  Periprocedural (Day 1) - during anesthetic injection phase

Study Arms (3)

Digital Anesthesia

EXPERIMENTAL

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

Device: Digital Anesthesia

Infiltration Anesthesia

ACTIVE COMPARATOR

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

Drug: Infiltration Anesthesia

Mandibular Block Anesthesia

ACTIVE COMPARATOR

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

Drug: Mandibular Block

Interventions

Digital Anesthesia DEVICE

Computer-controlled intraosseous anesthesia system (Dental Hi Tec, France) used to deliver 1.3 mL of 4% articaine with 1:200,000 epinephrine in two stages: gingival and intraosseous injection. The system provides consistent flow and reduced pain perception in children.

Also known as: SleeperOne 5

Digital Anesthesia

Infiltration Anesthesia DRUG

1 mL of 2% lidocaine with epinephrine was delivered via buccal infiltration using a conventional aspirating syringe and 27-gauge short needle. Topical benzocaine gel was applied for 30 seconds prior to injection.

Also known as: Lidocaine hydrochloride 2% with epinephrine 1:100,000

Infiltration Anesthesia

Mandibular Block DRUG

1 mL of lidocaine was administered using the inferior alveolar nerve block technique via a conventional dental syringe and 27-gauge long needle. Negative aspiration was confirmed prior to slow deposition.

Also known as: IANB

Mandibular Block Anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry

Istanbul, 34500, Turkey (Türkiye)

Location

Ege University Faculty of Dentistry Department of Pediatric Dentistry

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Atesci AA, Korkut Isik B, Yilmaz DO, Gergit B, Kilic MC, Oncag RO. Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Pediatric Dentistry? Int J Paediatr Dent. 2025 Oct 25. doi: 10.1111/ipd.70048. Online ahead of print.

  PMID: 41137566 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: January 8, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

TU (2)