Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Socket Preservations
• Intervention / Treatment: Combination product: PRGF/ATV; Drug: ATV gel; Biological: PRF; Biological: PRGF

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative ridge height	(Measured from stent reference point to the crest of the buccal or palatal plate of bone)	baseline (immediately after extraction) - After 2 months
Ridge width	(Measured from the buccal to palatal plate of bone using bone caliper)	baseline (immediately after extraction) - After 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Collagen surface area	after 2 months
Average tabecular size	after 2 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2012
• Primary Completion (Actual): March 12, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ASU-OMP-2012-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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