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RecruitingNCT05944341Updated Jul 13, 2023

Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four

An interventional study of articaine hydrochloride 4% with epinephrine 1:100 000 and Lidocaine hydrochloride 2% with epinephrine 1:100 000 in Dental Pulp Diseases, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 36 Months to 47 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Minia University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
36 Months to 47 Months
Sex
All
01

Study summary

A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.

The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)

02

Conditions studied

  • Dental Pulp Diseases
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's planned enrollment of 164 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months to 47 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
  • Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
  • Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis

Exclusion criteria

Exclusion Criteria:

  • Molars with unrestorable crowns
  • Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
164 participants (estimated)

Study arms

  • Experimental
    Articaine

    Drug: articaine hydrochloride 4% with epinephrine 1:100 000 · Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

  • Active comparator
    Lidocaine

    Drug: articaine hydrochloride 4% with epinephrine 1:100 000 · Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Interventions

  • Drugarticaine hydrochloride 4% with epinephrine 1:100 000

    Local anesthetic agent

  • DrugLidocaine hydrochloride 2% with epinephrine 1:100 000

    Local anesthetic agent

06

What researchers measure

Primary outcomes

  1. Face, Legs, Activity, Cry, Consolability pain scale

    its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10

    Time frame: up to 24 hours

07

Study locations

1 of 1 sites recruiting
  • Ahmad Elheeny
    Al Minyā, Al Minya 61111, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05944341
Lead sponsor
Minia University
Responsible party
Ahmad Elheeny (Assistant Professor, Minia University) — Principal investigator
First posted
Jul 13, 2023
Start date
Jun 1, 2023
Primary completion
Jul 15, 2023 (estimated)
Completion
Jul 15, 2023 (estimated)
Last update
Jul 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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