Topical simvastatin to improve bone healing after lower wisdom tooth extraction
Official title: Efficacy of Topical Application of Simvastatin in Bone Regeneration
Run by Universidad de Granada · NCT07031778 · Data updated 2026-11-12
This trial tests whether placing simvastatin directly into the tooth socket helps bone and soft-tissue healing after surgical removal of lower third molars.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Universidad de Granada Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Granada, Granada) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | January 7, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT07031778 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults ASA I–II who require surgical extraction of an included or partially included mandibular third molar, have the adjacent tooth present, are not taking systemic statins, are non-smokers, and can attend the University of Granada for surgery and follow-up.
✕Probably not a fit
Patients with metabolic bone disease, recent radiotherapy, current systemic statin therapy, heavy smoking, pregnancy or use of medications that impair bone healing are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a double-blind, randomized clinical trial at the University of Granada using mandibular third molar extraction as a model of post-extraction bone healing. Ninety third molars will be randomized into three groups: 1.2% simvastatin gel, a collagen sponge with 10 mg simvastatin in saline, or a collagen sponge in gel without simvastatin as control. Outcomes include changes in socket dimensions and bone density measured by CBCT at 12 weeks, plus soft-tissue healing and postoperative pain, inflammation and trismus. The trial is powered to 90% with a 95% confidence level and uses standardized surgical and follow-up procedures.
Why it matters
Potential benefit: If successful, topical simvastatin could reduce post-extraction bone loss and improve bone density and soft-tissue healing, potentially easing later implant or restorative procedures.
How similar studies have gone: Preclinical studies and small clinical reports have suggested topical statins can promote bone formation, but results are mixed and well-powered randomized trials in dental sockets are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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UGranada
Granada, Granada, Spain Recruiting
Study contacts
- Study coordinator: Manzano-Moreno FJ Francisco Javier Manzano-Moreno
- Email: fjmanza@ugr.es
- Phone: +34651606228
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.