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

607\43\7809

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.

2023-06-01

2023-11-28

2023-12-31

Not yet recruiting

Early phase I

200

Inclusion criteria: All patients have to meet all of the following inclusion criteria. They are eligible if: 1. They are Healthy (ASA 1: no acute or chronic disease, normal BMI percentile for age. 1. They are 36 to 47 months old children. 2. Intellectually qualified for communication. 3. They have under gone either clinically indicated gingival abscess, dental caries or pathological root resorption or periapical radiolucency showing on the radiograph. 4. Child's body weight at least 15 kg. 5. Ability to communicate effectively in the Arabic or English language. 6. Not taking any agents likely to interfere with reporting of pain (analgesics). 7. Needs any of the following procedure: Class I cavity, Class II cavity, pulpotomy, pulpectomy, stainless steel crown (SSC) or extraction. 8. Prior to enrollment, all radiographic data must be found acceptable by pediatric dentist. 9. Written and singed informed consent from legally acceptable representative. Exclusion criteria: Patients are excluded from the study if: 1. Patients have allergic to local anesthetic with epinephrine (sulphites or amide). 2. Intellectual or severe emotional problems. patient with intellectual development is significantly lower than average and his or her ability to adapt to the environment is consequently limited like autism, Down syndrome, fragile x syndrome, fetal alcohol syndrome, and Prader-Willi syndrome. 3. Considerable behavior problems. 4. Parents refuse participation in the trial. 5. History of previous bad dental experience. 6. Primary tooth who had a history of failed pulp therapy. 7. They have uncontrolled medical condition. 8. They use immunosuppressive agents, rifampin, or anticonvulsants, or any other medication. 9. Glucose 6 phosphate dehydrogenase deficiency. 10. Congenital cardiac diseases. 11. Seizures or uncontrolled epilepsy.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This is a prospective, randomized, clinical trial with two parallel arms, to evaluate the safety and efficacy of 4% Articaine, 2% Mepivacaine on vital and non-vital primary teeth that needs restorative, pulp therapy, or dental extraction by using buccal infiltration technique. The effect will be assessed by measuring the pain experience during injection and treatment procedures, and by assessing the child's behavior during the procedure, and postoperative pain and complications. The study consisted of a screening period for up to 6 months. A Qualified participants through the screening assessments will be assigned randomly to receive either 4% Articaine, or 2% Mepivacaine.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-05-03