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

Dental Pulp Diseases Clinical Trial

Official title:

Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944341
• Other study ID #: 778
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 47 Months

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Pulpitis

Intervention

Drug:
• articaine hydrochloride 4% with epinephrine 1:100 000
Local anesthetic agent
• Lidocaine hydrochloride 2% with epinephrine 1:100 000
Local anesthetic agent

Locations

Country	Name	City	State
Egypt	Ahmad Elheeny	Al Minya	Al Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 hours