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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain in Pediatric Dentistry Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital Anesthesia

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

Group Type EXPERIMENTAL

Digital Anesthesia

Intervention Type 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.

Infiltration Anesthesia

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

Group Type ACTIVE_COMPARATOR

Infiltration Anesthesia

Intervention Type 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.

Mandibular Block Anesthesia

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

Group Type ACTIVE_COMPARATOR

Mandibular Block

Intervention Type 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.

Interventions

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Digital Anesthesia

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.

Intervention Type DEVICE

Infiltration Anesthesia

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.

Intervention Type DRUG

Mandibular Block

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.

Intervention Type DRUG

Other Intervention Names

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SleeperOne 5 Lidocaine hydrochloride 2% with epinephrine 1:100,000 IANB

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes