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

Phase 4

Completed

• Conditions: Socket Preservation
• Interventions: Drug: ATV gel; Drug: PRGF/ATV

• Registration Number: NCT03228771
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-26
• Study Start: 2016-03
• Study First Submitted QC: 2017-07-22
• Study First Posted: 2017-07-25
• Primary Completion: 2018-06
• Study Completion: 2018-08-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATV gel	ATV gel	Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
PRGF/ATV	PRGF/ATV	Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF).

Primary Outcome Measures

Name	Time	Method
clinical measurements Ridge width	1 year	Ridge width

Secondary Outcome Measures

Name	Time	Method
clinical measurements ridge height	1 year	Ridge height

Trial Locations

Locations (1)

Faculty of dentistry-Ain shams University; 🇪🇬 Cairo, Egypt