Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-03-16
Brief Title:
Articaine Efficacy and Safety for 3 Years Old Children
Sponsor:
Qassim Health Cluster
Organization:
Qassim Health Cluster
Study Overview
Official Title:
Articaine Efficacy and Safety for 3 Years Old Children A Clinical Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childs 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 1100000 or 1200000 epinephrine Clinical trials comparing 4 with 2 solutions show no clinical advantage of 4 over a 2 solution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None