Clinical trial NCT05423392: Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children
Official title: Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children: A Double-blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Primary Teeth
Inferior Alveolar Nerve
Anesthesia, Dental
Keywords: Carticaine
Anesthesia, Dental
Pediatric Dentistry
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A RANDOMIZED DOUBLE BLIND
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale
timeFrame: during procedure
measure: Checkout of painlessness in lateral region lower jaw in children using tooth vitality test
timeFrame: 10 minutes after anesthetic injection
measure: Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale
timeFrame: during procedure
measure: Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale
timeFrame: during procedure
measure: Checkout of painlessness in lateral region lower jaw in children by determining the development of the roots of permanent teeth
timeFrame: before intervention
measure: Checkout of painlessness in lateral region lower jaw in children by determining the resorption of the roots of deciduous teeth
timeFrame: before intervention
Secondary outcomes:
measure: Success of indicated dental treatment using tooth vitality test
timeFrame: 10 minutes after dental treatment
measure: Success of indicated dental treatment using Visual Analog Scale
timeFrame: immediately after dental treatment
measure: Success of indicated dental treatment using Wong-Baker Pain Rating Scale
timeFrame: immediately after dental treatment
measure: Success of indicated dental treatment using Frank Behavior Rating Scale
timeFrame: immediately after dental treatment
Other outcomes:
measure: Success of indicated dental treatment using questionnaire
timeFrame: 15 minutes after dental treatment
Locations:
city: Novi Sad
country: Serbia
facility: Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
state: Vojvodina
Study officials:
affiliation: Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
name: Branislav V Bajkin, DMD, PhD
role: STUDY_CHAIR
affiliation: Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
name: Jelena Komšić, DMD
role: STUDY_DIRECTOR
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