Articaine Efficacy and Safety for Children Below Age of 4-years

Phase 1

Completed

• Conditions: Behaviour Assessment; Pain

• Registration Number: NCT04061265
• Lead Sponsor: Minia University

Brief Summary

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Study Start: 2019-08-25
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria

• The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain assessment	During the procedures	FLACC scale
Behavior	before and after the procedures	Frankl behaviour scale

Secondary Outcome Measures

Name	Time	Method
postoperative complications	24 hours after the procedures	Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)

Trial Locations

Locations (1)

Ngwa Khattab; 🇪🇬 Minya, Minia, Egypt