Effects of Different Centrifuged Platelet Concentrates on Bone Remodelling Around Dental Implants

NCT04851002 | Completed DMC

• 1 other identifier: 20.U.002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Platelet concentrates obtained from blood have been used as regenerative biomaterials in periodontal surgery. Along with the migration and proliferation of osteogenic cells, platelets accelerate bone regeneration by increasing the formation of blood vessels and inducing inflammatory reactions. Experimental studies revealed that growth factors released from platelets enhance osteoblastic differentiation on the implant surface, and enlarge the contact surface of the bone and implant. Platelet-rich fibrin (PRF), a platelet concentrate, was introduced by Choukroun in 2001, and it contains a significant amount of cytokines. Advanced-platelet rich fibrin (A-PRF), discovered in 2014, is a PRF derivative with a denser leukocyte concentration and a softer consistency. Concentrated growth factor (CGF), another platelet derivative, differs from A-PRF since it contains many concentrated growth factors trapped in a more rigid fibrin structure. It was reported that both A-PRF and CGF, obtained with variable centrifuge speeds, accelerated the proliferation and differentiation of bone cells. Stimulated osteoblasts and osteocytes initiate the remodelling process by producing macrophage colony-stimulating factor and receptor activator of nuclear factor-kappa B ligand (RANKL).Previous studies reported that TNF-α initiated bone resorption independently of RANKL.Osteoprotegerin (OPG) is a soluble cytokine receptor of the TNF family and is produced by osteoblasts, fibroblasts, and a number of host cells. OPG binds to RANKL and prevents the RANKL-RANK interaction Therefore, it inhibits osteoclastic activity. The RANKL/OPG ratio is used as an indicator for estimating bone remodelling, osteoclastic activity, or osteogenesis. The interactions among cytokines, growth factors, chemokines, and chemical mediators during blood clot formation result in a complex signalling process. High concentrations of cytokines and growth factors in the wound promote the migration of macrophages, neutrophils, and lymphocytes. Therefore, it was reported that the cytokines released from the fibrin matrix might affect those signaling pathways. In this study, investigators hypothesised that the application of CGF or A-PRF in dental implantation would contribute to inflammation, proliferation and the remodeling process. Therefore, the aim of this study was to investigate the effects of CGF and A-PRF on the osseointegration of dental implants in clinical, radiographic, and biochemical aspects.

Conditions

Edentulous Jaw; Bone Loss, Alveolar; Resorption, Bone

Keywords

Concentrated Growth Factor; Advanced Platelet Rich Fibrin; Inflammatory Cytokines; Implant Osseointegration; Peri-implant Crevicular Fluid

Outcome Measures

Primary Outcomes (16)

• Marginal Bone Loss

  Marginal bone loss measured around dental implants from mesial and distal surfaces on panoramic radiography obtained at the third month of the study.

  Third month

• Resonance Frequency Analysis-I

  Resonance frequency analysis is a method used to determine the primer stability in dental implants.

  Immediately after surgery

• Resonance Frequency Analysis-II

  Resonance frequency analysis is a method used to determine the primer stability in dental implants.

  Fourth week

• Resonance Frequency Analysis-III

  Resonance frequency analysis is a method used to determine the primer stability in dental implants.

  Third month

• TNF-alpha-I

  TNF-alpha isolated from peri-implanter crevicular fluid. The level of TNF-alpha has been analyzed by ELISA, and its level was determined as pg/dL

  Second week

• TNF-alpha-II

  TNF-alpha isolated from peri-implanter crevicular fluid. The level of TNF-alpha has been analyzed by ELISA, and its level was determined as pg/dL

  Fourth week

• TNF-alpha-III

  TNF-alpha isolated from peri-implanter crevicular fluid. The level of TNF-alpha has been analyzed by ELISA, and its level was determined as pg/dL

  Third month

• RANKL-I

  RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL

  Second week

• RANKL-II

  RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL

  Fourth week

• RANKL-III

  RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL

  Third month

• OPG-I

  OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL

  Second week

• OPG-II

  OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL

  Fourth week

• OPG-III

  OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL

  Third month

• RANKL/OPG ratio-I

  RANKL/OPG ratio is important for analysing bone remodeling and resorption process. RANKL/OPG ratio is obtained by dividing the RANKL level to the OPG level.

  Second week

• RANKL/OPG ratio-II

  RANKL/OPG ratio is important for analysing bone remodeling and resorption process. RANKL/OPG ratio is obtained by dividing the RANKL level to the OPG level.

  Fourth week

• RANKL/OPG ratio-III

  RANKL/OPG ratio is important for analysing bone remodeling and resorption process. RANKL/OPG ratio is obtained by dividing the RANKL level to the OPG level.

  Third month

Secondary Outcomes (12)

• Plaque Index-I

  Second week

• Plaque Index-II

  Fourth week

• Plaque Index-III

  Third month

• Gingival Index-I

  Second week

• Gingival Index-II

  Fourth week

Study Arms (4)

CGF TEST GROUP

EXPERIMENTAL

Concentrated growth factor liquid applied into the implant cavity. Also CGF membrane covered the implant and the socket. That is the only difference between CGF control group and CGF test group

Procedure: Application of concentrated growth factor with dental implants

A-PRF TEST GROUP

EXPERIMENTAL

Advanced Platelet Rich Fibrin liquid applied into the implant cavity. Also A-PRF membrane covered the implant and the socket. That is the only difference between A-PRF control group and A-PRF test group

Procedure: Application of advanced platelet rich fibrin with dental implants

CGF CONTROL GROUP

EXPERIMENTAL

Dental implant applications were made with traditional methods.

Procedure: Control side of concentrated growth factor study group

A-PRF CONTROL GROUP

EXPERIMENTAL

Dental implant applications were made with traditional methods.

Procedure: Control side of advanced platelet rich fibrin study group

Interventions

Application of concentrated growth factor with dental implants PROCEDURE

Concentrated growth factor(CGF) liquid applied to the implant cavity also CGF membrane covered socket and implant

CGF TEST GROUP

Application of advanced platelet rich fibrin with dental implants PROCEDURE

Advanced platelet rich fibrin (A-PRF) liquid applied to the implant cavity also A-PRF membrane covered socket and implant

A-PRF TEST GROUP

Control side of concentrated growth factor study group PROCEDURE

Traditional implant methods applied

CGF CONTROL GROUP

Control side of advanced platelet rich fibrin study group PROCEDURE

Traditional implant methods applied

A-PRF CONTROL GROUP

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years of age
• Symmetrical edentulous areas in the mandible
• Sufficient bone width and height permitting ideal dental implant placement
• Individuals who do not smoke
• At least 2 mm of keratinized gingiva width and 3 mm soft tissue thickness at the implant site

You may not qualify if:

• Patients with systemic disorders, including diabetes mellitus, metabolic bone disease, rheumatoid arthritis, mucocutaneous disorders, immunological disorders, hepatitis, or HIV
• Individuals who were on antibiotics, anti-inflammatory agents, corticosteroids, immunosuppressants, anticoagulants, or hormonal contraceptives for any reason, at least 6 months prior to the procedure, and those who were on bisphosphonates at that time or previously.
• Individuals with any pathology or defects at the implant site.
• History augmentation at the implant site.
• Individuals with severe periodontal disease and poor oral hygiene.
• Severe caries or endodontic lesions in teeth adjacent to the implant.
• Those who use intraoral orthodontic or prosthetic appliances that make plaque control difficult.
• Pregnant and lactating individuals.

Sponsors & Collaborators

• Muhammet Atilgan: lead
• Mustafa Kemal University: collaborator

Study Sites (1)

Mustafa Kemal University

Hatay, 31060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Jaw, Edentulous; Alveolar Bone Loss; Bone Resorption

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Bone Diseases; Periodontal Atrophy; Periodontal Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Osman Fatih ARPAG, PhD

  Mustafa Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group in which the patients were included was determined by pulling the closed envelope just before the surgery. Test side was determined by tossing a coin after the implant cavities were prepared but before the implants were placed. The examiners who carried out the measurements and analyzes were unaware of the study and the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: This is a split-mouth design study. Accordingly, our study was conducted on 40 patients, including 20 patients in the CGF(Concentrated Growth Factor) study group and 20 patients in the A-PRF(Advanced Platelet Rich Fibrin) study group. While the implant combined with any regenerative material (CGF or A-PRF) was applied to the test site randomly assigned in the mouth, dental implants were placed according to traditional methods without applying any additional material to the contralateral site. Implants were placed symmetrically in the region of incisors, premolars or molar teeth in the mandible.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 20, 2021
• Study Start: October 3, 2019
• Primary Completion: December 15, 2020
• Study Completion: March 20, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

TU (1)