Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)

Socket Preservation Clinical Trial

Official title:

Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228771
• Other study ID #: FDASU-RECM041515
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: September 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

Description:

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation.

Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich in growth factors which might be essential to proper tissue repair and wound healing. PRGF acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they do not exert any effects on the stem cells present in bone tissue, whose differentiation is regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a safe and cost effective alternative to this problem and can affect bone regeneration. Statins are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the osteoblasts from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 15, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.

• Both sexes.

• Age from 20 - 50 years old.

• Having at least one hopeless tooth indicated for extraction.

• Patient should agree to sign a written consent after the nature of the study will be explained.

Exclusion Criteria:

• Smokers.

• Pregnant and breast feeding females.

• Prisoners and handicapped patients.

Related Conditions & MeSH terms

• Socket Preservation

Intervention

Drug:
• PRGF/ATV
Atorvastatin loaded in PRGF fibrin scaffold
• ATV gel
Atorvastatin loaded in methyl cellulose gel

Locations

Country	Name	City	State
Egypt	Faculty of dentistry-Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	histomorphometric analysis	Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone	1 year
Primary	clinical measurements Ridge width	Ridge width	1 year
Secondary	clinical measurements ridge height	Ridge height	1 year