Articaine Efficacy and Safety for 3 Years Old Children

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05839548
• Other study ID #: 607\43\7809
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Behavior, Child
• Dental Caries
• Dental Caries in Children
• Dental Diseases
• Dental Pulp Diseases
• Pulp Disease, Dental
• Stomatognathic Diseases

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.