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IRCT20230627058604N1 IRCT 2023-12-26 Tabriz University of Medical Sciences Triparatide in dry socket and pain The effect of using gelatin sponges impregnated with Triparatide on the incidence of dry socket and pain intensity after tooth extraction 2023-10-23 anticipated 30 Complete https://irct.ir/trial/72540 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Two containers A and B are marked by the health personnel (the second supervisor of the thesis) that there is normal saline in one and the desired drug in the other. Without knowing the container containing the drug, the main researcher and the executive and the evaluator dipped each of the gelatin sponges in two different containers and placed them in the place of the two extracted teeth on both sides of the participant (for example, solution A is always on the left side of the participant, and solution B is placed on the right side of the patient.) Data analysis and drug effect evaluation are done after the completion of clinical procedures and notification of the principal investigator. 3 Pain and incidence of dry socket after tooth extraction. Intervention 1: Intervention group: On the side of the intervention (for example, the right side of the patient) and the place of the extracted tooth, a gelatin sponge immersed for 8 minutes in Triparatide solution 250 mcg/2.4 mL belonging to Sina Pharmaceutical Company was placed and a figur of eight suture will be applied and by VAS and objective observation of pain and occurrence of dry socket. It is evaluated at intervals of 24-72 hours and one week after tooth extraction. Please note that due to the split mouth study, the other side of the patient will be considered as the control group, and normal saline is used instead of Triparatide. Intervention 2: Considering the split mouth of the other side of the mouth study will be considered as the control group and normal saline will be used instead of triparatide and in double-blind conditions, which will be done in the same way as the intervention side and subsequent examinations. Yes - There is a plan to make this available What will be shared: Investigating the effect of triparatide solution on the amount of pain and incidence of dry socket after tooth extraction and all data, including entry and exit criteria, implementation method, study results and documentation, and information of participating patients in a non-identifiable condition with ethical indicators. When: Beginning the access period since mid 2024 To whom: Due to the need for skill and scientific information in the use of triparatide solution and the ability to make clinical judgment for its use, it will be available only to researchers working in academic and scientific institutions. Conditions: Use for systematic review studies Use for clinical strategy Use for retrospective studies Use to conduct similar studies with a new approach Where to obtain: Vice President of Research and Technology of Tabriz University of Medical Sciences How to obtain: Calling via email or visiting in person to the Vice President of Research and Technology of Tabriz University of Medical Sciences and requesting the use of documents according to the mentioned conditions. Comments:
public Farzin Ahmadpour Pournaki
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
Tabriz Iran (Islamic Republic of) 5145855359 +98 41 3236 7155 phoenixinfire@ymail.com Tabriz University of Medical Sciences scientific Farzin Ahmadpour Pournaki
Tabriz / Golgasht St. / Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Research and Technology Vice-Chancellor
Tabriz Iran (Islamic Republic of) 5145855359 +98 41 3236 7155 phoenixinfire@ymail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The patients with an indication for the extraction of lower molar teeth bilaterally (split mouth) 18 years 50 years Both Peri apical lesions Poor oral hygiene Smoking Alcoholism Diabetes Hyper tension (stg 2 =<) Other systemic disease Cancerous Pregnancy Treatment - Drugs Placebo Intervention group: On the side of the intervention (for example, the right side of the patient) and the place of the extracted tooth, a gelatin sponge immersed for 8 minutes in Triparatide solution 250 mcg/2.4 mL belonging to Sina Pharmaceutical Company was placed and a figur of eight suture will be applied and by VAS and objective observation of pain and occurrence of dry socket. It is evaluated at intervals of 24-72 hours and one week after tooth extraction. Please note that due to the split mouth study, the other side of the patient will be considered as the control group, and normal saline is used instead of Triparatide. Considering the split mouth of the other side of the mouth study will be considered as the control group and normal saline will be used instead of triparatide and in double-blind conditions, which will be done in the same way as the intervention side and subsequent examinations. Dry socket. Timepoint: 24hours, 72hours and one week after extraxtion. Method of measurement: VAS (Visual Analysis System) and objective examination. Tabriz University of Medical Sciences Approved 2023-09-10 Ethics committee of Tabriz University of Medical sciences No. 144, Shahid Chamran alley, Mofatteh ave Tabriz East Azarbaijan Iran (Islamic Republic of)