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Articaine Efficacy and Safety for 3 Years Old Children

Primary Purpose

Dental Caries in Children, Dental Diseases, Pulp Disease, Dental

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mepivacaine 2% with epinephrine 1:100,000
Articaine (4%) with epinephrine 1:100,000
Sponsored by
Qassim Health Cluster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring Articaine., Local anaesthesia., Child., Pain.

Eligibility Criteria

36 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    2% Mepivacaine with epinephrine 1:100,000.

    4% Articaine with epinephrine 1:100,000

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Change in respiratory rate (breaths per minute).
    The respiration rate is the number of breaths a person takes per minute.
    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).
    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.

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    March 16, 2023
    Last Updated
    May 1, 2023
    Sponsor
    Qassim Health Cluster
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05839548
    Brief Title
    Articaine Efficacy and Safety for 3 Years Old Children
    Official Title
    Articaine Efficacy and Safety for 3 Years Old Children: A Clinical Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    November 28, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qassim Health Cluster

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children, Dental Diseases, Pulp Disease, Dental, Behavior, Child
    Keywords
    Articaine., Local anaesthesia., Child., Pain.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2% Mepivacaine with epinephrine 1:100,000.
    Arm Type
    Active Comparator
    Arm Description
    Brand Name: 2% Medicaine with epinephrine 1:100,000.
    Arm Title
    4% Articaine with epinephrine 1:100,000
    Arm Type
    Experimental
    Arm Description
    Brand Name: 4% Septanest with epinephrine 1:100,000.
    Intervention Type
    Drug
    Intervention Name(s)
    Mepivacaine 2% with epinephrine 1:100,000
    Other Intervention Name(s)
    medicaine 2%
    Intervention Description
    Local Anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Articaine (4%) with epinephrine 1:100,000
    Other Intervention Name(s)
    septanest 4%
    Intervention Description
    Local Anesthesia
    Primary Outcome Measure Information:
    Title
    Change in systolic and diastolic blood pressure (mmHg).
    Description
    Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.
    Time Frame
    5 minutes before, during, and after 30 minutes of dental procedure.
    Title
    Change in pulse rate (beats per minute).
    Description
    Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
    Time Frame
    5 minutes before, during, and after 30 minutes of dental procedure.
    Title
    Change in respiratory rate (breaths per minute).
    Description
    The respiration rate is the number of breaths a person takes per minute.
    Time Frame
    5 minutes before, during, and after 30 minutes of dental procedure.
    Title
    Dental pain assessment: Frankl Behavior Rating Scale (FBRS).
    Description
    Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
    Time Frame
    up to 30 minutes after dental procedure.
    Title
    Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC).
    Description
    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.
    Time Frame
    up to 30 minutes after dental procedure.
    Secondary Outcome Measure Information:
    Title
    Post-operative complications.
    Description
    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).
    Time Frame
    24 hours after dental procedure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    36 Months
    Maximum Age & Unit of Time
    47 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Faisal Almogbel
    Phone
    00966505148946
    Email
    falmogbel@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asya A. Almansour, SBPD
    Phone
    00966569930211
    Email
    Dentist-asya@homail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murad A. Alrashdi, ABPD
    Organizational Affiliation
    Qassim University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Asya A. Almansour, SBPD
    Organizational Affiliation
    Ministry of Health, Qassim cluster.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Atyaf A. Alhunti
    Organizational Affiliation
    Qassim University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32223002
    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.
    Results Reference
    background
    PubMed Identifier
    32797942
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32383196
    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.
    Results Reference
    background
    PubMed Identifier
    34053801
    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.
    Results Reference
    background

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