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

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ClinicalTrials.gov Identifier: NCT03228771
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Noha Nasr, 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.

Condition or disease Intervention/treatment Phase
Socket Preservation Drug: PRGF/ATV Drug: ATV gel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).

Drug: PRGF/ATV
Atorvastatin loaded in PRGF fibrin scaffold
Other Name: platelets rich in growth factors

Active Comparator: 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.
Drug: ATV gel
Atorvastatin loaded in methyl cellulose gel
Other Name: Atorvastatin gel

No Intervention: 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.



Primary Outcome Measures :
  1. clinical measurements Ridge width [ Time Frame: 1 year ]
    Ridge width


Secondary Outcome Measures :
  1. clinical measurements ridge height [ Time Frame: 1 year ]
    Ridge height


Other Outcome Measures:
  1. histomorphometric analysis [ Time Frame: 1 year ]
    Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228771


Locations
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Egypt
Faculty of dentistry-Ain shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Khaled A Ghaffar, Professor Ain Shams University
Study Chair: Ola M Ezzatt, Lecturer Ain Shams University
  Study Documents (Full-Text)

Documents provided by Noha Nasr, Ain Shams University:
Study Protocol  [PDF] March 18, 2015
Statistical Analysis Plan  [PDF] March 18, 2015
Statistical Analysis Plan  [PDF] March 18, 2015


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Responsible Party: Noha Nasr, Researcher, Ain Shams University
ClinicalTrials.gov Identifier: NCT03228771    
Other Study ID Numbers: FDASU-RECM041515
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Keywords provided by Noha Nasr, Ain Shams University:
PRGF
Statins
socket augmentation
Additional relevant MeSH terms:
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Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors