Actively Recruiting

Early Phase 1
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT07031778

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UGranada

Granada, Granada, Spain, 18071

Actively Recruiting

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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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