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IRCT20180104038218N4 IRCT 2022-09-18 Qazvin University of Medical Sciences Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant 2022-09-23 anticipated 40 Complete https://irct.ir/trial/65841 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using an sealed envelope with an equal number of intervention (sweet taste) and control (water) samples is placed in a package and provided to the ward nurse, each time the nurse (Who has no role in the continuation of the study) pulls one of the envelopes and it is determined that the patient receives intervention or control, Blinding description: Outcome assessment is performed by a person other than the researcher and clinical caregiver and because he / she is present at the patient's bedside after the intervention, he / she is blind to the received intervention. The grouping results of each sample are delivered to the statistical analyzer in the form of numbers, so the analyzer is also blind. According to the sweet taste in the mouth of the intervention group, the participants are not blind. N/A treatment in pediatric dentistry. Intervention 1: Intervention group: Intervention group: In the first session, all children are subjected to brushing treatment and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the intervention group, pulp therapy of the maxillary molar is performed in the condition where sweet taste prevails in the mouth; Therefore, after anesthesia injection, the child kept a 25% sweet solution (25 g of sucrose (Merck, Germany) - 75 cc of distilled water) in the mouth for one minute, and then, honey is applied with a swab in the buccal vestibule of the mandible, in the opposite quadrant. If the honey is washed, this process is repeated every 2 minutes. Intervention 2: Control group: Control group: In the first session, all children are subjected to brushing and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the control group, the maxillary molar receives pulp therapy under normal conditions. In control group , after the anesthetic injection, the child holds normal water in his mouth for one minute and then spits it out. During the treatment, a dry swab is drawn in the buccal vestibule on the opposite side of the treatment and this is repeated every two minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Razieh Jabbarian
Bahonar Boulvard
Qazvin Iran (Islamic Republic of) 3471976160 +98 28 3335 3062 r.jabbarian@qums.ac.ir Qazvin University of Medical Sciences scientific Razieh Jabbarian
Bahonar Boulvard
Qazvin Iran (Islamic Republic of) 3471976160 +98 28 3335 3062 r.jabbarian@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) 4-6 year old children in need of maxillary first molar pulp treatment Physical health in terms of systemic and development positive behavior according to Frankel's classification (cooperative and without resistance to treatment) They should not eat or drink anything at least one hour before the treatment Without previous dental experience 4 years 6 years Both Allergy or contraindication regarding consumption of sweet substances Spontaneous/nocturnal pain or abscess in the target tooth Presence of pain, inflammation and any other problem in the treatment area If complete anesthesia was not achieved for the treatment, the patient will be excluded from the study G89.1 Acute pain, not elsewhere classified Treatment - Other Treatment - Other Intervention group: Intervention group: In the first session, all children are subjected to brushing treatment and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the intervention group, pulp therapy of the maxillary molar is performed in the condition where sweet taste prevails in the mouth; Therefore, after anesthesia injection, the child kept a 25% sweet solution (25 g of sucrose (Merck, Germany) - 75 cc of distilled water) in the mouth for one minute, and then, honey is applied with a swab in the buccal vestibule of the mandible, in the opposite quadrant. If the honey is washed, this process is repeated every 2 minutes Control group: Control group: In the first session, all children are subjected to brushing and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the control group, the maxillary molar receives pulp therapy under normal conditions. In control group , after the anesthetic injection, the child holds normal water in his mouth for one minute and then spits it out. During the treatment, a dry swab is drawn in the buccal vestibule on the opposite side of the treatment and this is repeated every two minutes. The objective level of pleasant treatment. Timepoint: during treatment. Method of measurement: FLACC( Face,leg,activity,crying,consolability). The objective level of pleasant treatment. Timepoint: after treatment. Method of measurement: Wong baker. Heart rate. Timepoint: before, during and after treatment. Method of measurement: pulse oximeter. Oxygen saturation. Timepoint: before, during and after treatment. Method of measurement: pulse oximeter. Qazvin university of medical sciences Approved 2022-08-03 Ethics Committee of Qazvin University of Medical Sciences Bahonar Boulvard Qazvin Qazvin Iran (Islamic Republic of)