Comparing articaine and lidocaine for dental procedures in young children
Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial
This study is testing whether articaine or lidocaine works better as a numbing medicine for young children getting dental work done for a painful tooth condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 36 Months to 47 Months |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Al Minyā, Al Minya) |
| Trial ID | NCT05944341 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial designed to compare the effectiveness of articaine versus lidocaine as local anesthesia in children under four years old suffering from irreversible pulpitis. The study will involve 164 healthy children, who will be randomly assigned to receive either articaine or lidocaine during pulpectomy procedures. Pain severity will be assessed using the FLACC scale, while behavior during the procedure will be evaluated with the Frankl behavior rating scale. The goal is to determine which anesthetic provides better outcomes in terms of pain management and patient cooperation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 36 to 47 months with irreversible pulpitis who are cooperative and weigh at least 15 kilograms.
Not a fit: Patients with unrestorable molars, necrotic pulps, or other severe dental issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for young children undergoing dental procedures.
How similar studies have performed: Other studies have shown varying success with local anesthetics in pediatric dentistry, but this specific comparison of articaine and lidocaine in this age group is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Molars with unrestorable crowns * Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
Where this trial is running
Al Minyā, Al Minya
- Ahmad Elheeny — Al Minyā, Al Minya, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.