Clinical trial NCT03231137: Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination
Official title: Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alveolar Socket Preservations
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Relative ridge height
timeFrame: baseline (immediately after extraction) - After 2 months
measure: Ridge width
timeFrame: baseline (immediately after extraction) - After 2 months
Secondary outcomes:
measure: Collagen surface area
timeFrame: after 2 months
measure: Average tabecular size
timeFrame: after 2 months
Other outcomes:
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