Articaine Efficacy and Safety for 3 Years Old Children

Sponsor

Qassim Health Cluster (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05839548

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children Dental Diseases Pulp Disease, Dental Behavior, Child	Drug: Mepivacaine 2% with epinephrine 1:100,000 Drug: Articaine (4%) with epinephrine 1:100,000	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Nov 28, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

Change in systolic and diastolic blood pressure (mmHg). [5 minutes before, during, and after 30 minutes of dental procedure.]
Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.
Change in pulse rate (beats per minute). [5 minutes before, during, and after 30 minutes of dental procedure.]
Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Change in respiratory rate (breaths per minute). [5 minutes before, during, and after 30 minutes of dental procedure.]
The respiration rate is the number of breaths a person takes per minute.
Dental pain assessment: Frankl Behavior Rating Scale (FBRS). [up to 30 minutes after dental procedure.]
Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC). [up to 30 minutes after dental procedure.]
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.

Secondary Outcome Measures

Post-operative complications. [24 hours after dental procedure.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 47 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

All patients have to meet all of the following inclusion criteria. They are eligible 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.

Exclusion criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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