Histomorphometric investigation of the effect of rosuvastatin on the repair of dental socket bone

Histomorphometric investigation of rosuvastatin on dental socket bone repair

A clinical trial with a control group (a parallel group where each individual will be compared to themselves), double-blinded (patients, surgeons, and evaluators), randomized phase 2-3 conducted on 14 patients. A coin toss will be used for randomization.

Patients who have referred to the Faculty of Dentistry of Islamic Azad University of Tehran for tooth extraction and implant placement with the indication of two identical removable teeth are selected and after both teeth are extracted in one session, rosuvastatin (Rosutex) with foam gel will be randomly placed in one of the sockets and Only gel foam will be placed in the other socket.Then the flap will be turned over and sutured to close the socket. At the next visit, which will be after 2 months for implant placement, samples of the tooth cavities will be taken for histological examination of bone quality.

Inclusion Criteria: Patients with two removable teeth, candidates for implants Exclusion Criteria: systemic diseases, diabetes, pregnancy, periodontitis, history of radiotherapy, use of steroids, allergic prophylaxis requirement

Intervention group: 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. Rosuvastatin (Ropixon 20, 20 mg, manufactured by Obidi Pharmaceutical Company) with foam gel will be placed in the socket. The flap will be turn and sutured to close the socket. Control group: The same individual in the intervention group, who will receive a placebo for their second dental socket.

percentage of living bone, percentage of necrotic bone, degree of inflammation, foreign body reaction

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.

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.