NCT07031778 (SM) is a EARLY_PHASE1 clinical trial of Simvastatin in Dimensional Changes, sponsored by Universidad de Granada.

Who is sponsoring NCT07031778?

NCT07031778 is sponsored by Universidad de Granada.

What drugs are being tested in NCT07031778?

Interventions in NCT07031778: Simvastatin, Simvastatin 10 mg, Simvastatin Placebo.

What condition does NCT07031778 study?

NCT07031778 studies Dimensional Changes, Bone Density.

Is NCT07031778 still recruiting?

NCT07031778 is currently recruiting now. Last updated 22 June 2025.

Last reviewed 2025-06-22 · How we verify

NCT07031778: SM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Topic Simvastatin for Bone Regeneration

Recruiting now EARLY_PHASE1 Last updated 22 June 2025

What this trial tests

EARLY_PHASE1 trial testing Simvastatin in Dimensional Changes in 90 participants. Currently enrolling.

Timeline

7 January 2025

Primary endpoint
7 January 2025

31 December 2025

Quick facts

Lead sponsor	Universidad de Granada
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	7 January 2025
Primary completion	7 January 2025
Estimated completion	31 December 2025
Sites	1 location across Spain

Drugs / interventions tested

Simvastatin (simvastatin) — full drug profile →
Simvastatin 10 mg — full drug profile →
Simvastatin Placebo

Conditions studied

Dimensional Changes — all drugs for Dimensional Changes →
Bone Density — all drugs for Bone Density →

Sponsor

Universidad de Granada — full company profile →

Who can join

Adults 18 to 40, any sex, with Dimensional Changes or Bone Density. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy of topical application of simvastatin gel combined with a collagen sponge carrier in preserving alveolar ridge dimensions: a triple-blind randomized clinical trial.
López-Andrade E, Manzano-Moreno FJ, Taboada V, Vallecillo C, et al · · 2026 · PMID 41876793 · DOI 10.1007/s00784-026-06832-9

Verify or expand the search:

Other trials of Simvastatin

Trials testing the same drug.

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Other Universidad de Granada trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07031778 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidad de Granada
Last refreshed: 22 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07031778.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing