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

NCT04149080 | Unknown

• 1 other identifier: SIM01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Simvastatin; Tooth extraction; Alveolar socket preservation; Bone regeneration

Outcome Measures

Primary Outcomes (1)

• Dimensional change of the alveolar crest

  Including soft and hard tissue, after clinical, histological and tomographic analysis

  90 days

Secondary Outcomes (2)

• Soft tissue healing

  1 week

• Pain/discomfort

  1 week

Study Arms (2)

SIM Group

EXPERIMENTAL

Alveolar socket post-extraction filled with Simvastatin covered with polypropylene membrane

Procedure: SIM + polypropylene membrane

Control Group

PLACEBO COMPARATOR

Alveolar socket post-extraction covered with polypropylene membrane

Procedure: Placebo

Interventions

SIM + polypropylene membrane PROCEDURE

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

SIM Group

Placebo PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years
• Healthy patients with indication for dental extraction
• Teeth adjacent to the extraction site
• Patients willing to cooperate with the study and who have signed the informed consent form.

You may not qualify if:

• Patients showing periapical or periodontal infection
• Patients with severe systemic diseases
• Patients on medications such as chemotherapy, anticoagulants, corticosteroids, biphosphonates and immunosuppressant drugs,
• Patients who have chronic diseases decompensated (e.g. hypertension, diabetes, rheumatic diseases, renal, and hepatic)
• Patients with bone diseases, metabolic (osteomalacia, hypocalcemia and hypercalcemia).

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Dental Clinical Research Center of the Fluminense Federal University

Niterói, Rio de Janeiro, 24020-140, Brazil

RECRUITING

Related Publications (4)

• Landry R, Turnbull R, Howley T. Effectiveness of benzydamine HCL in the treatment of periodontal post-surgical patients. Res Clin Forums 10:105-118, 1998

  BACKGROUND

• Moraschini V, Almeida DCF, Calasans-Maia JA, Diuana Calasans-Maia M. The ability of topical and systemic statins to increase osteogenesis around dental implants: a systematic review of histomorphometric outcomes in animal studies. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1070-1078. doi: 10.1016/j.ijom.2017.12.009. Epub 2018 Jan 17.

  PMID: 29352637 RESULT

• Barone A, Ricci M, Tonelli P, Santini S, Covani U. Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing. Clin Oral Implants Res. 2013 Nov;24(11):1231-7. doi: 10.1111/j.1600-0501.2012.02535.x. Epub 2012 Jul 12.

  PMID: 22784417 RESULT

• Calasans-Maia M, Resende R, Fernandes G, Calasans-Maia J, Alves AT, Granjeiro JM. A randomized controlled clinical trial to evaluate a new xenograft for alveolar socket preservation. Clin Oral Implants Res. 2014 Oct;25(10):1125-30. doi: 10.1111/clr.12237. Epub 2013 Aug 13.

  PMID: 23937306 RESULT

Study Officials

• Rebecca Cruz, MSc

  Fluminense Federal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Cruz, MSc

CONTACT

+5521987282551; rebecca.cruz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Model Details: 30 subjects will be divided randomly in two groups. The study is triple masked.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

BR (1)