Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

NCT ID: NCT03231137

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-16
• Study Completion Date: 2017-07-10

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.

Conditions

Alveolar Socket Preservations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PRGF/ATV

Intervention Type: COMBINATION_PRODUCT

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

ATV gel

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

Group Type: EXPERIMENTAL

ATV gel

Intervention Type: DRUG

Atorvastatin gel

PRF

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

Group Type: EXPERIMENTAL

PRF

Intervention Type: BIOLOGICAL

Platelet rich fibrin

PRGF

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

Group Type: EXPERIMENTAL

PRGF

Intervention Type: BIOLOGICAL

plasma rich in growth factor

Control

Spontaneously healed socket

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRGF/ATV

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

Intervention Type: COMBINATION_PRODUCT

ATV gel

Atorvastatin gel

Intervention Type: DRUG

PRF

Platelet rich fibrin

Intervention Type: BIOLOGICAL

PRGF

plasma rich in growth factor

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Ezzatt

Lecturer Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ASU-OMP-2012-9

Identifier Type: -

Identifier Source: org_study_id