Clinical trial NCT03228771: Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)
Official title: Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Socket Preservation
Keywords: PRGF
Statins
socket augmentation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical measurements Ridge width
timeFrame: 1 year
Secondary outcomes:
measure: clinical measurements ridge height
timeFrame: 1 year
Other outcomes:
measure: histomorphometric analysis
timeFrame: 1 year
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry-Ain shams University
Study officials:
affiliation: Ain Shams University
name: Khaled A Ghaffar, Professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Ola M Ezzatt, Lecturer
role: STUDY_CHAIR
References: