Dental Pulp Diseases
Conditions
Brief 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)
Interventions
DRUGarticaine hydrochloride 4% with epinephrine 1:100 000
Local anesthetic agent
Local anesthetic agent
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Months to 47 Months
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
* Molars with unrestorable crowns * Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability pain scale | up to 24 hours | its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10 |
Countries
Egypt
Outcome results
None listed