- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05839548
Articaine Efficacy and Safety for 3 Years Old Children
May 1, 2023 updated by: Qassim Health Cluster
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
Not yet recruiting
Intervention / Treatment
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 (Anticipated)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Faisal Almogbel
- Phone Number: 00966505148946
- Email: falmogbel@gmail.com
Study Contact Backup
- Name: Asya A. Almansour, SBPD
- Phone Number: 00966569930211
- Email: Dentist-asya@homail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
Local Anesthesia
Other Names:
|
Experimental: 4% Articaine with epinephrine 1:100,000
Brand Name: 4% Septanest with epinephrine 1:100,000.
|
Local Anesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systolic and diastolic blood pressure (mmHg).
Time Frame: 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.
|
5 minutes before, during, and after 30 minutes of dental procedure.
|
Change in pulse rate (beats per minute).
Time Frame: 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.
|
5 minutes before, during, and after 30 minutes of dental procedure.
|
Change in respiratory rate (breaths per minute).
Time Frame: 5 minutes before, during, and after 30 minutes of dental procedure.
|
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).
Time Frame: up to 30 minutes after dental procedure.
|
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).
Time Frame: 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.
|
up to 30 minutes after dental procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative complications.
Time Frame: 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).
|
24 hours after dental procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2023
Primary Completion (Anticipated)
November 28, 2023
Study Completion (Anticipated)
December 31, 2023
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)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Tooth Demineralization
- Tooth Diseases
- Dental Caries
- Dental Pulp Diseases
- Stomatognathic Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
- Mepivacaine
- Carticaine
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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