Topic Simvastatin for Bone Regeneration (NCT07031778) | Clinical Trial Compass
RecruitingEarly Phase 1
Topic Simvastatin for Bone Regeneration
Spain90 participantsStarted 2025-01-07
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dimensional changes
Timeframe: From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.