Articaine Efficacy and Safety for 3 Years Old Children

NCT05839548 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 607\43\7809
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children; Dental Diseases; Pulp Disease, Dental; Behavior, Child

Keywords

Articaine.; Local anaesthesia.; Child.; Pain.

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Post-operative complications.

  24 hours after dental procedure.

Study Arms (2)

2% Mepivacaine with epinephrine 1:100,000.

ACTIVE COMPARATOR

Brand Name: 2% Medicaine with epinephrine 1:100,000.

Drug: Mepivacaine 2% with epinephrine 1:100,000

4% Articaine with epinephrine 1:100,000

EXPERIMENTAL

Brand Name: 4% Septanest with epinephrine 1:100,000.

Drug: Articaine (4%) with epinephrine 1:100,000

Interventions

Mepivacaine 2% with epinephrine 1:100,000 DRUG

Local Anesthesia

Also known as: medicaine 2%

2% Mepivacaine with epinephrine 1:100,000.

Articaine (4%) with epinephrine 1:100,000 DRUG

Local Anesthesia

Also known as: septanest 4%

4% Articaine with epinephrine 1:100,000

Eligibility Criteria

• Age: 36 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. They are Healthy (ASA 1: no acute or chronic disease, normal BMI percentile for age.
• They are 36 to 47 months old children.
• Intellectually qualified for communication.
• They have under gone either clinically indicated gingival abscess, dental caries or pathological root resorption or periapical radiolucency showing on the radiograph.
• Child's body weight at least 15 kg.
• Ability to communicate effectively in the Arabic or English language.
• Not taking any agents likely to interfere with reporting of pain (analgesics).
• Needs any of the following procedure: Class I cavity, Class II cavity, pulpotomy, pulpectomy, stainless steel crown (SSC) or extraction.
• Prior to enrollment, all radiographic data must be found acceptable by pediatric dentist.
• Written and singed informed consent from legally acceptable representative.

You may not qualify if:

• Patients are excluded from the study if:
• Patients have allergic to local anesthetic with epinephrine (sulphites or amide).
• 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.
• Considerable behavior problems.
• Parents refuse participation in the trial.
• History of previous bad dental experience.
• Primary tooth who had a history of failed pulp therapy.
• They have uncontrolled medical condition.
• They use immunosuppressive agents, rifampin, or anticonvulsants, or any other medication.
• Glucose 6 phosphate dehydrogenase deficiency.
• Congenital cardiac diseases.
• Seizures or uncontrolled epilepsy.

Sponsors & Collaborators

• Qassim Health Cluster: lead

Study Sites (1)

Qassim University

Burayadh, Al-Qassim Region, 51452, Saudi Arabia

Location

Related Publications (5)

• 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.

  PMID: 32223002 BACKGROUND

• 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.

  PMID: 32797942 BACKGROUND

• 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.

  PMID: 32383196 BACKGROUND

• 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.

  PMID: 34053801 BACKGROUND

• Alrashdi M, Alhunti A, Almansour A. Efficacy and safety of articaine in 3-year-old children for dental procedures: a protocol for a clinical randomised control trial in Saudi Arabia. BMJ Open. 2023 Oct 21;13(10):e077751. doi: 10.1136/bmjopen-2023-077751.

  PMID: 37865418 DERIVED

MeSH Terms

Conditions

Stomatognathic Diseases; Dental Pulp Diseases; Child Behavior; Pain

Interventions

Mepivacaine; Epinephrine; Carticaine

Condition Hierarchy (Ancestors)

Tooth Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiophenes; Sulfur Compounds

Study Officials

• Murad A. Alrashdi, ABPD

  Qassim University

  STUDY CHAIR

• Asya A. Almansour, SBPD

  Ministry of Health, Qassim cluster.

  PRINCIPAL INVESTIGATOR

• Atyaf A. Alhunti

  Qassim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 3, 2023
• Study Start: July 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)