Articaine Efficacy and Safety for 3 Years Old Children

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children; Dental Diseases; Pulp Disease, Dental; Behavior, Child
• Intervention / Treatment: Drug: Mepivacaine 2% with epinephrine 1:100,000; Drug: Articaine (4%) with epinephrine 1:100,000

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Qassim
    • Burayadh, Qassim, Saudi Arabia, 51452
      • Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2% Mepivacaine with epinephrine 1:100,000.; Brand Name: 2% Medicaine with epinephrine 1:100,000.	Drug: Mepivacaine 2% with epinephrine 1:100,000; Local Anesthesia; Other Names: medicaine 2%
Experimental: 4% Articaine with epinephrine 1:100,000; Brand Name: 4% Septanest with epinephrine 1:100,000.	Drug: Articaine (4%) with epinephrine 1:100,000; Local Anesthesia; Other Names: septanest 4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Qassim Health Cluster
• Investigators: Study Chair: Murad A. Alrashdi, ABPD, Qassim University; Principal Investigator: Asya A. Almansour, SBPD, Ministry of Health, Qassim cluster.; Study Director: Atyaf A. Alhunti, Qassim University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Child.; Pain.; Articaine.; Local anaesthesia.
• Additional Relevant MeSH Terms: Tooth Diseases; Tooth Demineralization; Dental Pulp Diseases; Dental Caries; Stomatognathic Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate; Carticaine; Mepivacaine
• Other Study ID Numbers: 607\43\7809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No