Qassim University
Burayadh, Al-Qassim Region, 51452, Saudi Arabia
NCT Number: NCT05839548
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.
This study is active but is not currently recruiting participants.
Notify Me36 month–47 month
All sexes
Interventional
Phase 3
Burayadh, Al-Qassim Region, 51452, Saudi Arabia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients have to meet all of the following inclusion criteria. They are eligible if:
Exclusion criteria
Patients are excluded from the study if:
Local Anesthesia
Other names: medicaine 2%
Local Anesthesia
Other names: septanest 4%
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
The respiration rate is the number of breaths a person takes per minute.
Time frame: up to 30 minutes after dental procedure.
Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
Time frame: up to 30 minutes after dental procedure.
Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: relaxed and comfortable,1-3: mild discomfort, 4-6: moderate discomfort, 7-10: sever discomfort or pain or both.
Time frame: 24 hours after dental procedure.
asking the parent in next 24 hours from dental procedure, by using parents' post operative pain measure (PPPM). It will be dichotomized into absent (0-5) and present (6-15).
Qassim Health Cluster
Other
Articaine Efficacy and Safety for 3 Years Old Children: a Clinical Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06283108
Dental Caries in Children, Dental Diseases
Aurora, Colorado, United States
View Trial DetailsNCT05220865
Dental Caries in Children, Stomatognathic Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT04119180
Behavior, Child Behavior
Goiânia, Goiás, Brazil
View Trial DetailsNCT06290531
Dental Caries in Children, Neurologic Manifestations
Cairo, Egypt
View Trial Details