Topic Simvastatin for Bone Regeneration

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversidad de Granada

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Pregnant or lactating women.

Chronic smokers.

Patients with decompensated metabolic disease.

Patients with motor difficulties that prevent or hinder hygiene.

Trial design

Treatments tested in this trial

  • Simvastatin
  • Simvastatin 10 mg
  • Simvastatin Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators