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IRCT20250101064245N1 IRCT 2025-04-05 Islamic Azad University Investigating the effect of rosuvastatin on bone Histomorphometric investigation of the effect of rosuvastatin on the repair of dental socket bone 2025-02-19 anticipated 14 Complete https://irct.ir/trial/81123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be conducted using a purposive sampling method. The selection of the socket intended to be filled with rosuvastatin will occur through random allocation. In this manner, for each patient, the cavities will be organized in accordance with the Universal numbering system. In this method, the numbering of the upper jaw third molar on the left receives the number 1, and the remaining upper jaw teeth are sequentially numbered from left to right, such that the upper jaw third molar on the right receives the number 16. For the lower jaw, the numbering continues from the right third molar, which is assigned the number 17. Subsequently, the numbering continues sequentially from right to left, with the final tooth, the lower jaw third molar on the left, receiving the number 32. Accordingly, the tooth that is assigned a smaller number is designated as A, and the other tooth is designated as B. The allocation of the intervention type to teeth A and B will be executed using a random coin toss method, facilitated by the flipping of a coin. This process will be overseen by the study's statistical consultant and will take place prior to the implementation of the interventions. The outcomes of the random allocation will be provided to the researcher preparing the gel in sealed envelopes, which will be sequentially opened during the intervention to procure the gels accordingly, Blinding description: In this study, a placebo will also be utilized. The primary drug consists of a gel that is impregnated with rosuvastatin, while the placebo comprises a gel that is devoid of rosuvastatin. patients, researchers, and the surgical dentist will remain unaware of the contents of the gels (rosuvastatin + gel or gel alone). Patients will not be informed regarding which cavity contains the drug and which cavity contains the placebo. The surgical dentist will also lack information about the two groups and will only be provided with two packages labeled A and B. For each patient, after the cavities have been systematically numbered according to the Universal numbering system, package A will be applied to the tooth with the smaller number and package B to the other tooth. Additionally, When evaluating dependent variables by the assessor, they will also have no information regarding the type of medication or placebo in the examined cavities. 2-3 Dental implants and repairing dental socket. Intervention 1: "Intervention group:" In patients who have an indication for two identical extractable teeth, after extracting both teeth in one session, curettage and rinsing of the cavity with saline will be performed, and one of the sockets that will have a smaller number based on the universal numbering method will be selected. Rosuvastatin (Ropixon 20, 20 mg, manufactured by Obidi Pharmaceutical Company) will be mixed in the form of a powder mixture with gel foam powder (one 20 mg tablet) by normal saline and placed in the tooth socket. Then the flap will be turned over and sutured to close the socket opening. After 2 months, the patient will be called back and the dependent variables under study will be measured. Intervention 2: Control group: In this study, the control group will consist of the same patients as the intervention group (parallel control). Patients with two extractable teeth and candidates for implants, After tooth extraction using an elevator and forceps, the short implant procedure was performed, coupled with curettage and lavage of the socket with saline. foam gel (one 20 mg tablet in powder form) will be placed in the socket. The flap will be turn and sutured to close the socket. 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 Since this thesis is supported by the Research Department of Azad University in Tehran, after the completion of data collection, a written request must be submitted to the aforementioned department for the publication of the data. Upon approval from this department, the data will be published.
public Dr Sare Farhadi
No. 4, Neyestan 10 Alley, Pasdaran Street
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 dr.sfarhadi@gmail.com Islamic Azad University scientific Dr Sare Farhadi
No. 4, Neyestan 10 Alley, Pasdaran Street
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 dr.sfarhadi@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients applying for implant placement referred to the dental unit of Islamic Azad University Patients who have an indication of two matching teeth that can be extracted no limit no limit Both systemic diseases diabetes pregnancy periodontitis history of radiation therapy use of steroids needing allergic prophylaxis Z96.5 Presence of tooth-root and mandibular implants Treatment - Drugs Placebo "Intervention group:" In patients who have an indication for two identical extractable teeth, after extracting both teeth in one session, curettage and rinsing of the cavity with saline will be performed, and one of the sockets that will have a smaller number based on the universal numbering method will be selected. Rosuvastatin (Ropixon 20, 20 mg, manufactured by Obidi Pharmaceutical Company) will be mixed in the form of a powder mixture with gel foam powder (one 20 mg tablet) by normal saline and placed in the tooth socket. Then the flap will be turned over and sutured to close the socket opening. After 2 months, the patient will be called back and the dependent variables under study will be measured. Control group: In this study, the control group will consist of the same patients as the intervention group (parallel control). Patients with two extractable teeth and candidates for implants, After tooth extraction using an elevator and forceps, the short implant procedure was performed, coupled with curettage and lavage of the socket with saline. foam gel (one 20 mg tablet in powder form) will be placed in the socket. The flap will be turn and sutured to close the socket. Percentage of living bone. Timepoint: before the intervention and 2 months after the implant placement. Method of measurement: Nikon YS-100 optical microscope with 100 magnification and a scaled lens. Percentage of necrotic bone. Timepoint: before the intervention and 2 months after the implant placement. Method of measurement: Nikon YS-100 optical microscope with 100 magnification and a scaled lens. Degree of inflammation. Timepoint: before the intervention and 2 months after the implant placement. Method of measurement: Nikon YS-100 optical microscope with 100 magnification and a scaled lens. Foreign body reaction. Timepoint: before the intervention and 2 months after the implant placement. Method of measurement: Nikon YS-100 optical microscope with 100 magnification and a scaled lens. Islamic Azad University Approved 2024-11-30 Ethics Committee of Tehran Islamic Azad University No. 4, Neyestan 10 Alley, Pasdaran Street tehran Tehran Iran (Islamic Republic of)