NCT05423392

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Novi Sad · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years	Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.
PROCEDURE	Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years	Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.
PROCEDURE	Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years	Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.

Timeline

• Start date: 2021-12-02
• Primary completion: 2023-01-31
• Completion: 2023-02-01
• First posted: 2022-06-21
• Last updated: 2023-02-01

Locations

1 site across 1 country: Serbia