Topical simvastatin to improve bone healing after lower wisdom tooth extraction
Efficacy of Topical Application of Simvastatin in Bone Regeneration
EARLY_PHASE1 · Universidad de Granada · NCT07031778
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_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Universidad de Granada (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Granada, Granada) |
| Trial ID | NCT07031778 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Granada, Granada
- UGranada — Granada, Granada, Spain (RECRUITING)
Study contacts
- Study coordinator: Manzano-Moreno FJ Francisco Javier Manzano-Moreno
- Email: fjmanza@ugr.es
- Phone: +34651606228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dimensional Changes, Bone Density, simvastatin, bone density, dimensional changes, cbct scan