Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children
Condition: Dental Caries; Primary Teeth; Inferior Alveolar Nerve; Anesthesia, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      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: 
      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:

        1. Visual Analog Scales (VAS)

        2. Tooth vitality test

        3. Wong-Baker Pain Rating Scale (W-BFSR)

        4. Frank Behavior Rating Scale (FBRS)

        5. By determining the growth and development of the roots of permanent premolars and molars

        6. 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.
    

Intervention name(s): Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.; Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.; Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.
Other intervention name(s): 4% Articaine; Effectiveness of anesthetics; Lateral jaw region in children; 2% Lidocaine-chloride; 4% Articaine; Effectiveness of anesthetics; Lateral jaw region in children; 2% Lidocaine-chloride; 4% Articaine; Effectiveness of anesthetics; Lateral jaw region in children; 2% Lidocaine-chloride
Intervention MeSH terms: Lidocaine; Carticaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A RANDOMIZED DOUBLE BLIND
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carticaine; Anesthesia, Dental; Pediatric Dentistry