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Articaine Efficacy and Safety for Children Below Age of 4-years

Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04061265
Enrollment
184
Registered
2019-08-19
Start date
2019-08-25
Completion date
2020-01-15
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behaviour Assessment, Pain

Keywords

Articaine, local anaesthesia, child, pain

Brief summary

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Interventions

DRUGlidocaine hydrochloride 2% and epinephrine 1:100000

Local anesthetic agent

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
37 Months to 47 Months
Healthy volunteers
No

Inclusion criteria

* Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion criteria

* The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Design outcomes

Primary

MeasureTime frameDescription
Pain assessmentDuring the proceduresFLACC scale
Behaviorbefore and after the proceduresFrankl behaviour scale

Secondary

MeasureTime frameDescription
postoperative complications24 hours after the proceduresAsking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026