Actively Recruiting
Topic Simvastatin for Bone Regeneration
Led by Universidad de Granada · Updated on 2025-06-22
90
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Topic Simvastatin for Bone Regeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Anesthetic risk ASA I-II
- Presence of adjacent tooth (37 or 47)
- Fully developed roots of third molars
- Included or semi-included mandibular third molars
- Indication for extraction
- Signed informed consent
You will not qualify if you...
- Pregnant or lactating women
- Chronic smokers
- Decompensated metabolic disease
- Motor difficulties affecting hygiene
- Use of statins for hypercholesterolemia
- Treatment with chemotherapy, bisphosphonates, corticosteroids, or immunosuppressants
- Metabolic bone diseases or radiotherapy in the last five years
AI-Screening
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Trial Site Locations
Total: 1 location
1
UGranada
Granada, Granada, Spain, 18071
Actively Recruiting
Research Team
M
Manzano-Moreno FJ Francisco Javier Manzano-Moreno
CONTACT
L
Lopez-Andrade E Elena López-Andrade
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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