NCT05839548

Articaine Efficacy and Safety for 3 Years Old Children

Articaine Efficacy and Safety for 3 Years Old Children: a Clinical Randomized Control Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qassim Health Cluster · Academic / Other
• Sex: All
• Age: 36 Months – 47 Months
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to determine the local anesthetic efficacy and safety of 4% Articaine compared 2% Mepivicaine in 3 years old children, by using infiltration technique for primary teeth that required restorative, pulp therapy, or dental extraction procedure, as assessed by measuring the pain experience during injection and treatment procedures, child's behavior during the procedure, and postoperative complications.

Detailed description

Articaine has been widely used in dental surgery. Dentists started to use carticaine around 1977. In dentistry, articaine has been investigated extensively. Clinical trials comparing articaine mostly with lidocaine have varied in study design and site of action. The overwhelming majority of references in the literature describing the alleged neurotoxicity of articain concern paraesthesia and prolonged numbness after dental procedures. An excellent review of the dental literature was published last year. The authors concluded that articaine is a safe and effective local anesthetic drug to use in all aspects of clinical dentistry for patients of all ages, with properties comparable to other common local anesthetic agents. Although there may be controversy regarding its safety and advantages in comparison to other local anesthetics, there is no conclusive evidence demonstrating neurotoxicity or significantly superior anesthetic properties of articaine for dental procedures. The choice whether to use articaine or another local anesthetic is based on the personal preference and experiences of individual clinicians. 3Currently, articaine is available as a 4% solution containing 1:100,000 or 1:200,000 epinephrine. Clinical trials comparing 4% with 2% solutions show no clinical advantage of 4% over a 2% solution.

Conditions

• Dental Caries in Children
• Dental Diseases
• Pulp Disease, Dental
• Behavior, Child

Interventions

Type	Name	Description
DRUG	Mepivacaine 2% with epinephrine 1:100,000	Local Anesthesia
DRUG	Articaine (4%) with epinephrine 1:100,000	Local Anesthesia

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-05-03
• Last updated: 2024-12-27

Locations

1 site across 1 country: Saudi Arabia