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Topic Simvastatin for Bone Regeneration

RecruitingEARLY Phase 1Ages 18 Years - 40 YearsAllUniversidad de Granada
NCT07031778 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Anesthetic risk ASA I-II. * Patients with the adjacent tooth in the mouth (37 or 47). * Third molars with fully developed roots. * Mandibular third molars included or semi-included. * With indication for extraction. * Signed informed consent. Exclusion Criteria: * Pregnant or lactating women. * Chronic smokers. * Patients with decompensated metabolic disease. * Patients with motor difficulties that prevent or hinder hygiene. * Patients who are using statins to treat hypercholesterolemia. * Patients under treatment with drugs that could affect the osseointegration process such as chemotherapy drugs, bisphosphonates, corticosteroids or immunosuppressants. * Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.
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What it tests

  • Simvastatin
  • Simvastatin 10 mg
  • Simvastatin Placebo
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Where

1 site
UGranada
Granada, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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