Topic Simvastatin for Bone Regeneration

Summary

The goal of this clinical trial is to evaluate the efficacy of topical application of simvastatin in bone regeneration in the maxillae, in the reduction of dimensional bone changes, using mandibular third molar surgery as a model and assessing bone healing at 12 weeks. We will also compare the two forms of intralveolar topical administration currently used to assess which is the best form of administration. The main questions it aims to answer are: * Can the topical application of simvastatin, used as a preservation material, improve the variations with respect to bone dimensions and density that occur after tooth extraction. * Can topical application of SM improve soft tissue healing. * Does the topical application of SM produce changes with respect to postoperative variables of pain, inflammation or trismus. * What is the best vehicle for topical SM administration? For this purpose, the investigators will randomly place 4 topical treatment options in the postextraction alveoli: * SM in gel form * collagen sponge impregnated with saline solution containing 10 mg of SM * collagen sponge with placebo gel. All patients will undergo postoperative CBCT, which will be repeated at 12 weeks. In addition, inflammation, trismus and pain variables will be measured preoperatively, at 24 hours, 3 and 7 days.

Timeline

Start

2025-01-07

Primary completion

2025-01-07

Completion

2025-12-31

Publications

• Results Degala S, Bathija NA. Evaluation of the Efficacy of Simvastatin in Bone Regeneration after Surgical Removal of Bilaterally Impacted Third Molars-A Split-Mouth Randomized Clinical Trial. J Oral Maxillofac Surg. 2018 Sep;76(9):1847-1858. doi: 10.1016/j.joms.2018.04.035. Epub 2018 May 31.
• Results Cruz R, Moraschini V, Calasans-Maia MD, de Almeida DCF, Sartoretto SC, Granjeiro JM. Clinical efficacy of simvastatin gel combined with polypropylene membrane on the healing of extraction sockets: A triple-blind, randomized clinical trial. Clin Oral Implants Res. 2021 Jun;32(6):711-720. doi: 10.1111/clr.13740. Epub 2021 Mar 27.
• Results Deepanjali M, Prasad TS, Manodh P. Efficacy of simvastatin in bone regeneration after surgical removal of mandibular third molars. Oral Maxillofac Surg. 2023 Sep;27(3):427-432. doi: 10.1007/s10006-022-01081-y. Epub 2022 Jun 1.
• Results Diniz JA, Barbirato DDS, do Nascimento EHL, Pontual ADA, Dourado ACAG, Laureano Filho JR. Tomographic evaluation of the effect of simvastatin topical use on alveolar bone microarchitecture, pain and swelling after mandibular third molar extraction: a randomized controlled trial. Clin Oral Investig. 2022 Apr;26(4):3533-3545. doi: 10.1007/s00784-021-04322-8. Epub 2022 Jan 22.

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Indications