Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four
Not Applicable
Recruiting
- Conditions
- Dental Pulp Diseases
- Registration Number
- NCT05944341
- Lead Sponsor
- Minia University
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 164
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ahmad Elheeny
🇪🇬Al Minyā, Al Minya, Egypt