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IRCT20210908052409N1 IRCT 2022-01-24 Shahid Beheshti University of Medical Sciences Comparison of the Effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on Pain and Anxiety Reduction due to Dental Injection in Primary Teeth Comparison of the Effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on Pain and Anxiety Reduction due to Dental Infiltration Anesthesia in Primary Upper Teeth 2020-09-25 anticipated 21 Complete https://irct.ir/trial/59599 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Blinding description: Participant is not aware of the type of topical anesthesia before dental injection. Also , a dental assistant as an outcome adjudicator doesn't know about the type of experimental agent . 3 Pain and anxiety due to anesthesia infiltration injection in pediatric dentistry. Intervention 1: Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes and in the second session 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. In both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent . Intervention 2: Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds and in the second session 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. Same as the previos group, in both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent . Yes - There is a plan to make this available What will be shared: The recorded data can be shared based on the studied indicators after identifying the sample individuals, These data include the numbers and scores reported from the Wong Baker FACES Pain Rating Scale, Houpt Scale, and numbers recorded from the finger pulse oximeter at specified times, as well as the results of statistical analysis of these data. When: e.g., starting 6 months after publication To whom: Researchers working in academic and scientific institutes can apply for access to the data. Conditions: Performing statistical analyzes to compare data with other studies in this field is one of the conditions for access to data, so the analysis must be appropriate to the type of data received from the applicant. Where to obtain: Applicants can obtain access to the data by submitting a request to the following emails in due time. Moderator: Bardia Hasani Email address: bardia.hasani@gmail.com WhatsApp number: +989012879632 How to obtain: After submitting the request by email and also sending the request to WhatsApp of the specified person, the applicant will be able to access the information within one week after submitting the request, if she has the requisite conditions. Comments:
public Kiana Poorzandpoush
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2242 4428 Kianapoorzand@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ali asghar soleimani
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2211 2187 drsoleymaniali@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 4-9 years old children Children without systemic diseases Children without history of previous dental treatment Requiring two symmetric posterior primary upper teeth infiltration injection 4 years 9 years Both Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes and in the second session 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. In both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent . Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds and in the second session 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. Same as the previos group, in both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent . The perceived pain degree using Wong Baker Faces Pain scale(wbfps), the assessed pain and anxiety using children’s Hospital of Eastern Ontario Pain Scale (CPS), heart rate ratio using pulse oximeter. Timepoint: Recording the degree of perceived pain after injection using Wong Baker Facial Pain Scale(wbfps) . Pain and anxiety assessment using CPS Scale during injection. Assessment of heart rate before, during and after injection using pulse oximeter device . Method of measurement: Recording the degree of perceived pain after injection using Wong Baker Facial Pain Scale . Pain and anxiety assessment using CPS Scale during injection. Assessment of heart rate before, during and after injection using pulse oximeter device . Shahid Beheshti University of Medical Sciences Approved 2020-08-25 Ethics committee of Shahid Beheshti University of Medical Sciences School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)