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Effects of Simvastatin Gel on Bone Neoformation in Post-extraction Sockets: a Randomized Controlled Trial

NCT04149080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-04

No results posted yet for this study

Summary

Statins (HMG-CoA) are widely used in treating patients with hypercholesterolemia. They have also been studied because of their anabolic effects on bone tissue. Statins increase the expression of Bone Morphogenetic Proteins-2 (BMP-2) and Vascular Endothelial Growth Factor (VEGF), which are of important scientific interest in bone regeneration therapy. However, they are expensive and have a short half-life. Therefore, a molecule promoting the endogenous production of BMP-2 and VEGF would be valuable for the field of bone tissue engineering. This study aims to evaluate dimensional changes, level of soft tissue healing, pain/discomfort, and newly formed tissues in post-extraction sockets filling with Simvastatin (SIM) gel covered with polypropylene membranes. Thirty post-extraction sockets of posterior teeth will be randomized allocated in two groups: 1) extractions and socket filling with 1.2% SIM gel and membrane and 2) extraction and socket filling with placebo gel and membrane. The evaluation will be done through clinical analyzes, histomorphometry and micro-computed tomographic images, considering the dimensional changes, the quantity and the quality of tissue formation after extractions. Measurements will be taken before extraction (T1) and 90 days after the extraction (T2). In addition, the perception of pain will be analyzed. The hypothesis is that SIM associated with polypropylene membrane can enhance bone formation in post-extraction sockets compared with the control group.

Conditions

  • Alveolar Socket Preservation
  • Bone Regeneration

Interventions

PROCEDURE

SIM + polypropylene membrane

After tooth extraction the socket will be filled with 1.2% simvastatin gel and covered with polypropylene membrane, which will be intentionally exposed.

PROCEDURE

Placebo

After tooth extraction the socket will be filled with gel and covered with polypropylene membrane, which will be intentionally exposed.

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Rebecca Cruz, MSc · Fluminense Federal University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Brazil

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 NCT04149080 on ClinicalTrials.gov