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IRCT20180104038218N3 IRCT 2022-04-09 Qazvin University of Medical Sciences Evaluation of the effect of sweet odor on pain level of upper jaw anesthesia in children 7-9 years old Evaluation of sweet aromatherapy effect on pain level of maxillary primary molars infiltration anesthesia in 7-9 years old children 2022-04-30 anticipated 48 Complete https://irct.ir/trial/61922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in blocked randomization method and blocking and sequencing of samples will be done with random allocation software; The names of the groups are then placed in envelopes from 1 to 48 and placed in a box, respectively. The researcher who will make the random assignment will not be aware of the contents of the envelopes and the contents of the envelopes indicate the study groups (anesthesia in the saturated environment of odor, sudden exposure to odor and control) and after ensuring that the sample enters the research and Obtaining written consent, the first envelope is removed in order and placed in one of the study groups according to the content of the envelope, 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. N/A injection in pediatric dentistry. Intervention 1: Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The intervention group is placed in a room saturated with a sweet smell during injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Intervention 2: Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The second intervention group is exposed to a sudden sweet odor(with a higher saturation than the first intervention group) just during the injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Intervention 3: Control group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The control group is placed in the injection room and is not exposed to any odor. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. 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) children 7-9 years old requiring maxillary molar infiltration systemic and developmental health Positive behavior according to Frankle classification (cooperative and without resistance to treatment) Do not eat or drink anything for at least one hour before the injection 7 years 9 years Both ear, nose, throat disorders allergy, sinusitis or tonsillitis current cold or any other smelling disorder The presence of spontaneous / nocturnal pain or abscess in the desired tooth Pain, inflammation and any other problems in the injection site child's previous dental experiment G89.1 Acute pain, not elsewhere classified Treatment - Other Treatment - Other Treatment - Other Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The intervention group is placed in a room saturated with a sweet smell during injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The second intervention group is exposed to a sudden sweet odor(with a higher saturation than the first intervention group) just during the injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Control group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The control group is placed in the injection room and is not exposed to any odor. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Objective level of pain. Timepoint: after completion of anesthesia. Method of measurement: Face,leg,activity,crying,consolability (FLACC). Subjective pain level. Timepoint: after injection completion. Method of measurement: Wong baker. Heart rate. Timepoint: before, during and after injection. Method of measurement: pulse oximeter. Oxygen saturation. Timepoint: before, during and after injection. Method of measurement: pulse oximeter. Qazvin university of medical sciences Approved 2022-01-23 Ethics Committee of Qazvin University of Medical Sciences Bahonar Boulvard Qazvin Qazvin Iran (Islamic Republic of)