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

Minia University164 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

164

Conditions

Dental Pulp Diseases

Interventions

articaine hydrochloride 4% with epinephrine 1:100 000DRUG

Local anesthetic agent

Lidocaine hydrochloride 2% with epinephrine 1:100 000DRUG

Local anesthetic agent

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 47 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ahmad Elheeny

Minya, Minya Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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