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IRCT20220917055974N1 IRCT 2022-10-28 Tehran University of Medical Sciences The effect of using sweet-tasting solutions on pain perception caused by dental anesthesia injections in children The effect of administrating a sweet-tasting solution (30% Sucrose solution) in comparison to distilled water on pain perception caused by dental anesthesia injections in children aged of 6-10 years old: a randomized controlled trial 2022-09-29 anticipated 48 Complete https://irct.ir/trial/65950 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The total number of children will randomly be divided into two groups of 24 people, case and control, using the block randomization method. The randomization unit will be individual. Numbers 1 to 48 will be written on similar papers and will be placed in similar closed envelopes. Half of these envelopes are placed in the intervention group and the other half in the control group. Randomization will done by a person who has no familiarity with the study protocol. Similar laboratory containers will be labeled with numbers 1 to 48. According to the numbers in the control and intervention groups, laboratory containers are filled with sucrose solution or distilled water. The person who fills the laboratory containers has no knowledge of the study process, Blinding description: Participation in this study will be with the full consent of the parents of the patients, but the patient or his parents will not know that they are in the control or intervention group. A person who divides the numbers 1 to 48 into two groups will not know about the study protocol. Next, the person who fills the laboratory containers with sucrose solution in the intervention group and distilled water in the control group is not familiar with the study. A dentist who administers anesthetic injections to children and observes and records the child's behavior related to pain does not know the type of solution used by the child. 3 Dental caries with pulp exposure. Intervention 1: Intervention group: Sucrose solution 30%, chemical formula C12H22O11, produced by Millipore Sigma, in the amount of 20 ml, is kept in the mouth for one minute before injection and then is emitted. Intervention 2: Control group: Distilled water, with the chemical formula H2O, produced by the 3 Sib Teb company, in the amount of 20 ml before injection, is kept in the mouth for one minute and then is emitted out. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data file of the participants will be subjected to statistical analysis and the results will be published in the form of an article. The data file of the participants will not contain more useful information and includes personal information.
public Elahe Darvishi
South Sajjad blvd
Tehran Iran (Islamic Republic of) 1369993494 +98 21 6621 2744 elahedarvishi467@yahoo.com Tehran University of Medical Sciences scientific Elahe Darvishi
South Sajjad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1369993495 +98 21 6621 2744 elahedarvishi467@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Children 6 to 10 years old Having at least one mandibular primary molar that needs pulp therapy Willingness and permission of parents to participate in the study 6 years 10 years Both Dental emergencies such as traumatic dental injuries or tooth pain Non-cooperation of children Allergy to lidocaine or sweet substances such as sucrose Existence of previous anesthesia experience Presence of abscess, redness, and fistula at the injection site Presence of systemic medical conditions (ASA class I or II) History of hospitalization History of previous dental treatment History of mental or anxiety disorders K02 Dental caries Prevention Placebo Intervention group: Sucrose solution 30%, chemical formula C12H22O11, produced by Millipore Sigma, in the amount of 20 ml, is kept in the mouth for one minute before injection and then is emitted. Control group: Distilled water, with the chemical formula H2O, produced by the 3 Sib Teb company, in the amount of 20 ml before injection, is kept in the mouth for one minute and then is emitted out. Visual analogue scale grade. Timepoint: Visual analog scale score measurement immediately after the intervention. Method of measurement: Visual analog scale: a spectrum with 10 numbers and schematic images next to the numbers, in which the patient expresses the amount of pain caused by the injection that he has experienced with the help of these numbers, and the greater the pain, the closer the number will be to 10. Sound, eye, body movement grade. Timepoint: Measure the score of sound, eye, body movement, immediately after the intervention. Method of measurement: sound, eye, body movement grade: a pain measurement tool that measures pain intensity based on three characteristics of sound, eye movements and body movement. The amount of pain shows a number between 0 and 9, which we consider 3 points for each characteristic. Tehran University of Medical Sciences Approved 2022-04-26 Ethics committee of Tehran University of Medical Sciences No. 54 , Kohansal alley., South Sajjad Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)