A Randomized Controlled Trial of the Acceptance of Two Computer-controlled Anaesthetic Delivery Systems in Paediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Assessed at the end of each anaesthesia session, at both the first and second study visits
Study Overview
Brief Summary
This randomized, single-blind, split-mouth trial compares the acceptance of two computer-controlled local anaesthetic delivery (CCLAD) systems - Wand® STA and SleeperOne⑤ - in children aged 4-9 years undergoing comparable bilateral dental treatment. Each child receives local anaesthesia via both devices at separate visits, with pain, behaviour, heart rate, and oxygen saturation recorded at each session, to determine whether the two systems differ in child acceptance and physiological response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 4 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non-contributory medical history
- •At least one tooth requiring the same treatment on each side of the same jaw
- •Teeth on both sides with normal periodontium and no periapical pathology (confirmed radiographically)
Exclusion Criteria
- •Age outside 4-9 years
- •History of psychiatric or developmental illness, or allergies
- •Use of analgesic medication in the preceding 12 hours
- •History of unpleasant dental treatment experiences
Arms & Interventions
Wand STA → SleeperOne
Participants received local anaesthesia using the Wand® STA computer-controlled delivery system at the first treatment session, followed by the SleeperOne⑤ system at the second session, for comparable bilateral dental treatment (split-mouth design).
Intervention: Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type) (Device)
Wand STA → SleeperOne
Participants received local anaesthesia using the Wand® STA computer-controlled delivery system at the first treatment session, followed by the SleeperOne⑤ system at the second session, for comparable bilateral dental treatment (split-mouth design).
Intervention: Computer-controlled local anesthetic delivery system (corded, pen-style electronic type) (Device)
SleeperOne → Wand STA
Participants received local anaesthesia using the SleeperOne⑤ computer-controlled delivery system at the first treatment session, followed by the Wand® STA system at the second session, for comparable bilateral dental treatment (split-mouth design).
Intervention: Computer-controlled local anesthetic delivery system (pressure-sensing, single-tooth anesthesia type) (Device)
SleeperOne → Wand STA
Participants received local anaesthesia using the SleeperOne⑤ computer-controlled delivery system at the first treatment session, followed by the Wand® STA system at the second session, for comparable bilateral dental treatment (split-mouth design).
Intervention: Computer-controlled local anesthetic delivery system (corded, pen-style electronic type) (Device)
Outcomes
Primary Outcomes
Assessed at the end of each anaesthesia session, at both the first and second study visits
Time Frame: Periprocedural
After the second anaesthetic injection, children rated their pain or discomfort using the Wong-Baker FACES Pain Rating Scale, administered by a trained examiner blinded to which device had been used. The scale presents six faces corresponding to scores of 0, 2, 4, 6, 8, and 10, where 0 indicates "no hurt" and 10 indicates "hurts worst"; higher scores indicate greater pain (a worse outcome). Children selected the face that best matched how they felt immediately after the injection
Wong-Baker FACES Pain Score During Local Anaesthesia Injection
Time Frame: Immediately following completion of the first local anaesthesia injection, prior to the start of dental treatment
After each anaesthetic injection, children rated their pain or discomfort using the Wong-Baker FACES Pain Rating Scale, administered by a trained examiner blinded to which device had been used. The scale presents six faces ranging from 0 (no hurt) to 10 (hurts worst), with children selecting the face that best matched how they felt. Scores were recorded once per session, after the first (Wand® STA or SleeperOne⑤, per randomized sequence) and again after the second anaesthetic delivery visit, allowing comparison both between devices and between sessions.
Secondary Outcomes
No secondary outcomes reported
Investigators
Victoria Katechi
Post Graduate Student
National and Kapodistrian University of Athens