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Recruiting NCT07101068

Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

No phase Interventional Dental Caries Reversible Pulpitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dental Anesthesia Injector, conventional syringe.
Who it may be relevant to
Registry conditions: Dental Caries, Reversible Pulpitis. Basic parameters: 6 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Overview

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

Detailed description

This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.

The study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.

Each child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).

To evaluate pain and anxiety, the following tools will be used:

Pain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.

Interventions

  • Device Dental Anesthesia Injector
    Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.
  • Other conventional syringe
    Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Primary outcome measures

  • Pain during injection [Time frame: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.]
  • Anxiety felt by the patient [Time frame: the scale will be used at day 1 of anesthesia injection]
Secondary outcome measures (1)
  • Need for additional anesthesia [Time frame: The assessment will be done during dental visit at day 1 of anesthesia injection]

Eligibility criteria

Inclusion criteria

  • normal healthy patients (ASA I)
  • Undergoing the first dental local anesthesia experience
  • Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
  • Score 3 or 4 of Frankl scale of child behavior

Exclusion criteria

  • Presence of gingivitis, dental abscess, facial trauma/ injury
  • Administration of analgesic 48 h before randomization
  • Presence of allergy from local anesthesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Other

Study locations

Egypt · 2 centers
  • Ain Shams University — Cairo
  • Faculty of dentistry, Ain Shams University — Cairo

Publications

  • Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3. PMID 36627224

Identifiers

NCT: NCT07101068 · FDSU-Rec IMO12441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗