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Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231137
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ola Mohamed Ezzatt, Ain Shams University

Brief Summary:
This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.

Condition or disease Intervention/treatment Phase
Alveolar Socket Preservations Combination Product: PRGF/ATV Drug: ATV gel Biological: PRF Biological: PRGF Phase 4

Detailed Description:

Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as part of the natural physiological healing process. There are many techniques in the literature used for socket preservation as bone grafts, barrier membranes, immediate implant and socket shield. Many other techniques also are used such as bone and tissue healing promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the widely used group of cholesterol lowering drugs which also increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area of growth factors, there is no high-quality evidence to either support or refuse their use.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)
Actual Study Start Date : June 16, 2012
Actual Primary Completion Date : March 12, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRGF/ATV
Included 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket.
Combination Product: PRGF/ATV
Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold

Experimental: ATV gel
Included 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket.
Drug: ATV gel
Atorvastatin gel

Experimental: PRF
Included 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket.
Biological: PRF
Platelet rich fibrin

Experimental: PRGF
Included 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket.
Biological: PRGF
plasma rich in growth factor

No Intervention: Control
Spontaneously healed socket



Primary Outcome Measures :
  1. Relative ridge height [ Time Frame: baseline (immediately after extraction) - After 2 months ]
    (Measured from stent reference point to the crest of the buccal or palatal plate of bone)

  2. Ridge width [ Time Frame: baseline (immediately after extraction) - After 2 months ]
    (Measured from the buccal to palatal plate of bone using bone caliper)


Secondary Outcome Measures :
  1. Collagen surface area [ Time Frame: after 2 months ]
  2. Average tabecular size [ Time Frame: after 2 months ]


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:

  • 1. Both genders, aged from 20 to 50 years
  • 2. Patients free from any systemic diseases
  • 3. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated for crown preparation such as tooth with subgingival caries, broken roots, periodontally affected teeth, remaining roots) in the premolar and first molar area.
  • 4. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels in relation to cement-enamel junction of the pre-extracted tooth and remain intact postextraction as determined by clinical examination and periapical radiographs
  • 5. Patient agreed to sign a written consent after explanation of study nature.

Exclusion Criteria:

  • 1. Smokers.
  • 2. Pregnant and breast feeding females.
  • 3. Previous radiation, chemotherapy, or immunosuppressive treatments.
  • 4. Known hypersensitivity to statin drugs.
  • 5. Teeth with periapical infections, type II or III sockets or with dehiscence or fenestrations
  • 6. Vulnerable groups such as (Prisoners and handicapped or mentally disabled)

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Responsible Party: Ola Mohamed Ezzatt, Lecturer Dr., Ain Shams University
ClinicalTrials.gov Identifier: NCT03231137    
Other Study ID Numbers: ASU-OMP-2012-9
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atorvastatin
Mitogens
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Mitosis Modulators