Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children

Study Overview
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Brief Summary
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Optimal anesthesia is an essential requirement for successful dentoalveolar intervention.To achieve this goal,different anesthetic agents and techniques are available. Inferior alveolar nerve block (IANB) remains the most commonly used anesthetic technique. However, after the worldwide approval of articaine, a relatively new local anesthetic with enhanced tissue diffusion properties, many studies on healthy volunteers have investigated the anesthetic efficacy of buccal articaine infiltration and IANB in the mandibular posterior teeth and reported comparable results. Infiltration anesthesia is technically more straightforward, less stressful to the patient, and associated with higher success and lower complication rates than block anesthesia. The aim of this study was to determine the effectiveness of local infiltration anesthesia using 4% articaine in the analgesia of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years.

Detailed Description
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Clinical study to evaluate the effectiveness of local anesthesia with 4% articaine in order to ensure painless and effective implementation of dental procedures in children. Selection of respondents: participians with good systemic health - patients classified as American Society of Anesthesiologists (ASA) classification - ASA I and ASA II will be included in the study and required invasive dental treatment using local anesthetic (restoration or extraction) on deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, over 20 kg of body weight.The research would include at least 60 participials aged 5-18, who would be divided into two groups. One group the local anesthetic 4% articaine would be used. The second group would be provided with the local anesthetic 2% lidocaine chloride, as a control group. Analysis and data collection in each group would create subgroups depending on the age of the participials: 5-9 years, 10-13 years and 14-18 years.A clinical study would be doubly blind. Participials who would be included in the clinical study would sign a consent form to participate in the clinical study but would not know which anesthetic would be received.Criteria for measuring efficacy would be to measure pain during anesthetic injection,10 minutes after injection, and during and after the intervention using: Visual Analog Scales (VAS) Tooth vitality test Wong-Baker Pain Rating Scale (W-BFSR) Frank Behavior Rating Scale (FBRS) By determining the growth and development of the roots of permanent premolars and molars By determining the resorption of the roots of deciduous molars. The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist(examiner) who is in charge of measuring the effectiveness of anesthetics but does not know what type of anesthetic. Only a dentist who applies(practitioner) an anesthetic will know what type of anesthetic it is. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian). In accordance with known ethical principles and in accordance with the principles of Good Clinical Practice (GCP), care for the well-being of the patients was maximally respected, in accordance with the latest revision of the Declaration of Helsinki and accepted principles that apply to clinical trials on humans. The holder of the protection of the patients in this clinical trial is the principal researcher, who cooperated with the Ethics Committee of the Dental Clinic of Vojvodina, University of Novi Sad. The patients written Informed Consent implied that the patient had received full information about the research, and was stressed that they had the right to decide independently to participate, without coercion and external influences, or any harmful consequences if they refused to participate.

Official Title
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Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children: A Double-blind Randomized Study

Conditions
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Dental Caries, Primary Teeth, Inferior Alveolar Nerve, Anesthesia, Dental

Intervention / Treatment
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* Procedure: Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
* Procedure: Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
* Procedure: Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Respondents of both sexes, aged 5-18 years Subjects in need of either conservative rehabilitation or tooth extraction on deciduous or permanent premolars and / or molars Subjects who have an X-ray of the teeth for the need of dental rehabilitation Exclusion Criteria: difficult cooperation with the patient existence of allergy to local anesthetic the existence of a diagnosed general disease unsigned informative consent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A RANDOMIZED DOUBLE BLIND
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The first tasted group using 4% Articaine<br>The group was divided into three subgroups depending on the age of the participials: 1st group from 5-9 years, 2nd from 10-13 years and 3th from 14-18 years. Following placement of 5% lidocaine topical anaesthetic for 3 minutes prior to and at the site of needle penetration, patients were randomly given one of the following local anesthetic regimes administered by the principle investigator. For indicated dental treatment patients would receive 2.0 ml 4% articaine with 1:100,000 epinephrine as a local infiltration in the mucobuccal region,the lateral region of the lower jaw.Criteria for measuring efficacy would be to measure pain during anesthetic injection, 10 minutes after injection,during and after the intervention. The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist( examiner) using the above methodology. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian). | Procedure: Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.<br>* Other names: 2% Lidocaine-chloride;Procedure: Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.<br>* Other names: 2% Lidocaine-chloride;Procedure: Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.<br>* Other names: 2% Lidocaine-chloride;|
| Active Comparator: The second tasted group using 2% Lidocaine-chloride<br>The group was divided into three subgroups depending on the age of the participials: 1st group from 5-9 years, 2nd from 10-13 years and 3th from 14-18 years. Following placement of 5% lidocaine topical anesthetic for 3 minutes prior to and at the site of needle penetration, patients were randomly given one of the following local anesthetic regimes administered by the principle investigator. For the indicated dental treatment will be used 2.0 ml 2% lidocaine with 1:80,000 epinephrine as an IANB anesthesia for n.alveolaris inferior. Criteria for measuring efficacy would be to measure pain during anesthetic injection, 10 minutes after injection,during and after the intervention. The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist( examiner) using the above methodology. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian). | Procedure: Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.<br>* Other names: 2% Lidocaine-chloride;Procedure: Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.<br>* Other names: 2% Lidocaine-chloride;Procedure: Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years<br>* Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.<br>* Other names: 2% Lidocaine-chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale | Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale from 0 to 10, where 0 means absence of pain and 10 means unbearable pain. | during procedure | 
| Checkout of painlessness in lateral region lower jaw in children using tooth vitality test | Control and verification of painlessness of the anesthetized lower jaw region will be performed 10 minutes after anesthetic injection using a tooth vitality test. | 10 minutes after anesthetic injection | 
| Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale | Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale from 0 to 10, where 0 means absence of pain and 10 means the strongest possible pain. | during procedure | 
| Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale | Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale from 0 to 2 , where 0 means cooperating patient and 2 means complete lack of cooperation. | during procedure | 
| Checkout of painlessness in lateral region lower jaw in children by determining the development of the roots of permanent teeth | By determining the growth and development of the roots of permanent premolars and molars by examiner using x-ray before intervention. | before intervention | 
| Checkout of painlessness in lateral region lower jaw in children by determining the resorption of the roots of deciduous teeth | By determining the resorption of the roots of deciduous molars by examiner using x-ray before intervention. | before intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of indicated dental treatment using tooth vitality test | The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using tooth vitality test 10 minutes after dental treatment. | 10 minutes after dental treatment | 
| Success of indicated dental treatment using Visual Analog Scale | The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Visual Analog Scale from 0 to 10, where 0 means absence of pain and 10 means unbearable pain. | immediately after dental treatment | 
| Success of indicated dental treatment using Wong-Baker Pain Rating Scale | The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Wong-Baker Pain Rating Scale from 0 to 10, where 0 means absence of pain and 10 means the strongest possible pain. | immediately after dental treatment | 
| Success of indicated dental treatment using Frank Behavior Rating Scale | The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Frank Behavior Rating Scale from 0 to 2 , where 0 means cooperating patient and 2 means complete lack of cooperation. | immediately after dental treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carticaine, Anesthesia, Dental, Pediatric Dentistry