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Completed

NCT Number: NCT03231137

Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PRGF/ATV

Combination Product

Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold

ATV gel

Drug

Atorvastatin gel

PRF

Biological

Platelet rich fibrin

PRGF

Biological

plasma rich in growth factor

Primary outcomes

  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 outcomes

  1. Collagen surface area

    Time frame: after 2 months

  2. Average tabecular size

    Time frame: after 2 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.