Anesthesia injections for various dental treatments.
Conditions
Interventions
Intervention 1: Control group: Standard acidic local anesthesia injection available on the market for dental treatment in children who meet the inclusion criteria for the study. Intervention 2: Interv
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Physical Health: (No acute or chronic diseases and allergies), (No respiratory infections or fever, no antibiotic use in the last 3 weeks). Mental Health: (Living with both parents, having minimal stress and anxiety evaluated using the Beck Anxiety Inventory (BAI) Scale. The BAI questionnaire consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms over the past week. Scores can range from 0 to 63: minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63)). The child must have a Frankl cooperation rating of 3 or 4. The child should be in the primary dentition or mixed dentition stage. (Since each child is compared with themselves using the split-mouth method, there is no age limitation). No history of receiving local dental anesthesia No use of medications that interact with local anesthetic solutions and sodium bicarbonate or alter pain perception (e.g., Percocet, aspirin, lorazepam, etc.). Having two corresponding molars in one jaw that require local anesthesia for similar treatment. (Similar treatments include extractions, restorations, pulpotomy, and pulpectomy for primary molars, as well as extractions, restorations, and vital pulp therapy for first permanent molars or premolars). (Dental signs and symptoms: both corresponding teeth in two quadrants of one jaw requiring similar treatment are asymptomatic or have provoked pain).
Exclusion criteria
Exclusion criteria: Child non-cooperation during injection or dental treatment in the first or second session. Refusal of the patient or their parents to continue participation in the study. Presence of any lesions in the injection area, such as: fistula, abscess, ulcer, etc. Failure to achieve anesthesia and the need for a second injection. Treatment of two corresponding teeth in one jaw should not be similar.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate measurement by a dental resident. Timepoint: In two stages of treatment, the heart rate per minute is measured and compared before and after the injection to assess pain and anxiety. Method of measurement: Pulse oximeter.;Determining the pain index during anesthesia injection by a trained assistant. Timepoint: Five minutes after the injection, 0.5 milliliters from the tip of the syringe is injected into the mesial papilla of the tooth in question, and this process is repeated every minute for up to five times until the child indicates comfort or mild discomfort based on the SEM scale, which is recorded as the onset time of anesthesi. Method of measurement: SEM index: which is used in all three stages of anesthesia injection to evaluate the patient's behavior according to Table (1).;Pain assessment in children. Timepoint: Pain assessment in children is performed by determining the Wong-Baker score based on the child's self-report, which is measured at one stage (after the injection) by showing the child standard emoticons. Method of measurement: A child's Wong-Baker score is typically determined using the Wong-Baker Faces Pain Rating Scale. The scale consists of two parts: a numerical part for older children and a pictorial part for younger children. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbolfazl Shiri
Kerman University of Medical Sciences
Outcome results
None listed