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Topic Simvastatin for Bone Regeneration

NCT07031778 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-22

No results posted yet for this 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.

Conditions

  • Dimensional Changes
  • Bone Density

Interventions

DRUG

Simvastatin

Simvastatin gel with 1.2% simvastatin

DRUG

Simvastatin 10 mg

sponge of collagen impregned in saline solution with 10 mg of simvastatin

DRUG

Simvastatin Placebo

Collagen sponge impregned in simvastatin placebo gel without simvastatin

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2025-01-07
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031778 on ClinicalTrials.gov