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Topic Simvastatin for Bone Regeneration
Sponsor: Universidad de Granada
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.
Official title: Efficacy of Topical Application of Simvastatin in Bone Regeneration
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-01-07
Completion Date
2025-12-31
Last Updated
2025-06-22
Healthy Volunteers
Yes
Conditions
Interventions
Simvastatin
Simvastatin gel with 1.2% simvastatin
Simvastatin 10 mg
sponge of collagen impregned in saline solution with 10 mg of simvastatin
Simvastatin Placebo
Collagen sponge impregned in simvastatin placebo gel without simvastatin
Locations (1)
UGranada
Granada, Granada, Spain