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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05839548
Other study ID # 607\43\7809
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Qassim Health Cluster
Contact Faisal Almogbel
Phone 00966505148946
Email falmogbel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months to 47 Months
Eligibility 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.

Study Design


Intervention

Drug:
Mepivacaine 2% with epinephrine 1:100,000
Local Anesthesia
Articaine (4%) with epinephrine 1:100,000
Local Anesthesia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qassim Health Cluster

References & Publications (4)

Brignardello-Petersen R. Articaine and lidocaine probably have similar effects in 3- to 4-year-old children undergoing pulpotomy of a primary molar. J Am Dent Assoc. 2020 Oct;151(10):e93. doi: 10.1016/j.adaj.2020.06.029. Epub 2020 Aug 11. No abstract available. — View Citation

Elheeny AAH. Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial. Int J Paediatr Dent. 2020 Sep;30(5):547-555. doi: 10.1111/ipd.12640. Epub 2020 Apr 13. — View Citation

Massignan C, Silveira Santos P, Cardoso M, Bolan M. Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. J Oral Rehabil. 2020 Aug;47(8):1031-1040. doi: 10.1111/joor.12989. Epub 2020 May 25. — View Citation

Rayati F, Haeri M, Norouziha A, Jabbarian R. Comparison of the efficacy of 4% articaine with epinephrine 1:100,000 and 2% lidocaine with epinephrine 1:100,000 buccal infiltration for single maxillary molar extraction: a double-blind, randomised, clinical trial. Br J Oral Maxillofac Surg. 2021 Jul;59(6):695-699. doi: 10.1016/j.bjoms.2020.09.009. Epub 2020 Sep 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes before, during, and after 30 minutes of dental procedure.
Primary 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. 5 minutes before, during, and after 30 minutes of dental procedure.
Primary Change in respiratory rate (breaths per minute). The respiration rate is the number of breaths a person takes per minute. 5 minutes before, during, and after 30 minutes of dental procedure.
Primary 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). up to 30 minutes after dental procedure.
Primary 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. up to 30 minutes after dental procedure.
Secondary 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). 24 hours after dental procedure.
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