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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Local Anesthesia
Local Anesthesia
Qassim University
Burayadh, Al-Qassim Region, Saudi Arabia
Change in systolic and diastolic blood pressure (mmHg).
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.
Change in pulse rate (beats per minute).
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.
Change in respiratory rate (breaths per minute).
The respiration rate is the number of breaths a person takes per minute.
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
Dental pain assessment: Frankl Behavior Rating Scale (FBRS).
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.
Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC).
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: up to 30 minutes after dental procedure.
Post-operative complications.
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).
Time frame: 24 hours after dental procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.