Articaine Efficacy and Safety for 3 Years Old Children
- Conditions
- Dental DiseasesPulp Disease, DentalBehavior, ChildDental Caries in Children
- Registration Number
- NCT05839548
- Lead Sponsor
- Qassim Health Cluster
- 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, 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in systolic and diastolic blood pressure (mmHg). 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.
Change in pulse rate (beats per minute). 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.
Change in respiratory rate (breaths per minute). 5 minutes before, during, and after 30 minutes of dental procedure. The respiration rate is the number of breaths a person takes per minute.
Dental pain assessment: Frankl Behavior Rating Scale (FBRS). up to 30 minutes after dental procedure. Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC). 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.
- Secondary Outcome Measures
Name Time Method Post-operative complications. 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).
Trial Locations
- Locations (1)
Qassim University
🇸🇦Burayadh, Qassim, Saudi Arabia