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

NCT ID: NCT03228771

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-08-15

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.

Conditions

Socket Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

PRGF/ATV

Intervention Type: DRUG

Atorvastatin loaded in PRGF fibrin scaffold

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.

Group Type: ACTIVE_COMPARATOR

ATV gel

Intervention Type: DRUG

Atorvastatin loaded in methyl cellulose gel

Empty socket

Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRGF/ATV

Atorvastatin loaded in PRGF fibrin scaffold

Intervention Type: DRUG

ATV gel

Atorvastatin loaded in methyl cellulose gel

Intervention Type: DRUG

Other Intervention Names

platelets rich in growth factors; Atorvastatin gel

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Noha Nasr

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled A Ghaffar, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Ola M Ezzatt, Lecturer

Role: STUDY_CHAIR

Ain Shams University

Locations

Faculty of dentistry-Ain shams University

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FDASU-RECM041515

Identifier Type: -

Identifier Source: org_study_id