Analysing the Effects of Advanced-platelet Rich Fibrin and Concentrated Growth Factor on Implant Osseointegration With Respect to the Levels of TNF-α, RANKL, and OPG in Peri-implant Crevicular Fluid: a Split-mouth Design Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Marginal Bone Loss
研究概览
简要总结
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.
详细描述
This study was conducted in Periodontology clinics. The study protocol was approved by the Hatay Mustafa Kemal University Human Ethics Committee before the initiation of the study (approval number:). The patients who met the inclusion criteria and who volunteered to participate in the study were given detailed information about the study and provided informed consent before the procedure.
Patient selection:
The inclusion criteria of the individuals found to be healthy from their medical histories and who had received clinical examination and had radiological imaging were as follows:
- 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
Individuals meeting any of the criteria listed below were excluded from the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Marginal Bone Loss
时间窗: Third month
Marginal bone loss measured around dental implants from mesial and distal surfaces on panoramic radiography obtained at the third month of the study.
TNF-alpha-I
时间窗: Second week
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
Resonance Frequency Analysis-II
时间窗: Fourth week
Resonance frequency analysis is a method used to determine the primer stability in dental implants.
Resonance Frequency Analysis-III
时间窗: Third month
Resonance frequency analysis is a method used to determine the primer stability in dental implants.
Resonance Frequency Analysis-I
时间窗: Immediately after surgery
Resonance frequency analysis is a method used to determine the primer stability in dental implants.
RANKL-III
时间窗: Third month
RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL
OPG-III
时间窗: Third month
OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL
RANKL/OPG ratio-I
时间窗: Second week
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.
TNF-alpha-II
时间窗: Fourth week
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
TNF-alpha-III
时间窗: Third month
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
RANKL-I
时间窗: Second week
RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL
RANKL-II
时间窗: Fourth week
RANKL isolated from peri-implanter crevicular fluid. The level of RANKL has been analyzed by ELISA, and its level was determined as pg/dL
OPG-I
时间窗: Second week
OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL
OPG-II
时间窗: Fourth week
OPG isolated from peri-implanter crevicular fluid. The level of OPG has been analyzed by ELISA, and its level was determined as pg/dL
RANKL/OPG ratio-II
时间窗: Fourth week
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.
RANKL/OPG ratio-III
时间窗: Third month
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.
次要结局
- Plaque Index-I(Second week)
- Plaque Index-II(Fourth week)
- Gingival Index-IIII(Third month)
- Probing Depth-I(Second week)
- Plaque Index-III(Third month)
- Gingival Index-I(Second week)
- Gingival Index-II(Fourth week)
- Gingival Bleeding Index-I(Second week)
- Probing Depth-II(Fourth week)
- Probing Depth-III(Third month)
- Gingival Bleeding Index-II(Fourth week)
- Gingival Bleeding Index-III(Third month)
研究者
Muhammet Atilgan
Researcher
Mustafa Kemal University