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Clinical Trials in Spain / NCT07031778
Recruiting Early Phase 1

Topic Simvastatin for Bone Regeneration

NCT07031778 · tracked via the Priya Life Science Spain tracker
Sponsor
Universidad de Granada
Phase
Early Phase 1
Started
2025-01-07
Last updated
2025-06-22

Condition(s) studied

Dimensional ChangesBone Density

Investigational drug(s) / intervention(s)

Simvastatin →Simvastatin 10 mg →Simvastatin Placebo

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Dimensional changes — From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.
    The primary variable to be studied will be the bone dimensional changes that occur after tooth extraction, both horizontally and vertically. These will be assessed by means of CBCT scans carried out immediately postoperatively (T0) and 12 weeks later (T1).

Trial sites (1)

FacilityCityRegionStatus
UGranada Granada Granada Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07031778 on ClinicalTrials.gov ↗ ← All trials in Spain