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RECRUITING
NCT07031778
EARLY_PHASE1

Topic Simvastatin for Bone Regeneration

Sponsor: Universidad de Granada

View on ClinicalTrials.gov

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.

Official title: Efficacy of Topical Application of Simvastatin in Bone Regeneration

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-01-07

Completion Date

2025-12-31

Last Updated

2025-06-22

Healthy Volunteers

Yes

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

Locations (1)

UGranada

Granada, Granada, Spain