Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Tumor Necrosis Factor Alpha-TNF-α
研究概览
简要总结
Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.
详细描述
Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.
Thirty patients with chronic periodontitis who had at least two sites with perriodontal pocket depth (PPD) ≥ 4 mm on contralateral side will be involved in the study. Using a split-mouth design, patients will be treated with SRP + I-PRF -(test group) or SRP only-(control group). Gingival crevicular fluid (GCF) and subgingival plaque will be collected with paper points (DentsplyMaillefer, Tulsa, Oklahoma, USA) at baseline and 1, 3 and 6 months after the treatment. The presence and concentrations of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Tannerella forsythia(Tf) will be analyzed by real-time polymerase chain reaction (qPCR). Periodontal parameters, including bleeding on probing (BOP), probing pocket depth (PPD) and the clinical attachment level (CAL), will be recorded on both sides, as well as concentration of TNF-alpha (tumor necrosis factor alpha), ALP(alkaline phosphatase) and MMP-8 (matrix-metalloproteinase-8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A minimum of 6 teeth per quadrant;
- •A minimum of 2 teeth in each quadrant with a probing depth (PD) ≥5 mm;
- •Bleeding on probing (BOP) had to be at ≥40% tooth sites;
- •No involvement of furcation;
- •Good general health.
排除标准
- •Periodontal therapy within last 12 months;
- •Having surgical therapy;
- •Use of antibiotics over the last 6 months;
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis;
- •Pregnancy or nursing;
- •Current and former smokers.
研究组 & 干预措施
SRP + Injectable Platelet-Rich Fibrin
Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin
干预措施: SRP + Injectable Platelet-Rich Fibrin (Drug)
SRP + placebo
Scaling and root planing in conjunction with saline
干预措施: SRP + placebo (Drug)
结局指标
主要结局
Tumor Necrosis Factor Alpha-TNF-α
时间窗: baseline measure (before the intervention)
concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Periodontal Pocket Depth-PPD - 3m
时间窗: after 3 months
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Periodontal Pocket Depth-PPD - 6
时间窗: after 6 months
assessment of periodontal pocket depth by probing mean value of one side of the jaw
Level of Gingival Margin-LGM - 3m
时间窗: after 3 months
assessment of level of gingival margin-LGM by probing, i.e. distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw
Clinical Attachment Level- CAL
时间窗: baseline measure (before the intervention)
assessment of clinical attachment level- CAL by probing
Periodontal Pocket Microorganisms - 3m
时间窗: after 3 months
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.
Periodontal Pocket Depth-PPD - 1m
时间窗: after 1 month
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Level of Gingival Margin-LGM
时间窗: baseline measure (before the intervention)
assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw
Level of Gingival Margin-LGM - 6m
时间窗: after 6 months
assessment of level of gingival margin-LGM by probing, distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva) after 6 months
Clinical Attachment Level- CAL - 1m
时间窗: after 1 month
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Bleeding on Probing-BOP - 1m
时间窗: after 1 month
assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).
Periodontal Pocket Depth-PPD
时间窗: baseline measure (before the intervention)
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Level of Gingival Margin-LGM - 1m
时间窗: after 1 month
assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw
Bleeding on Probing-BOP
时间窗: baseline measure (before the intervention)
assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m
时间窗: after 3 months
Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m
时间窗: after 1 month
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.
Clinical Attachment Level- CAL - 3m
时间窗: after 3 months
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Clinical Attachment Level- CAL - 6m
时间窗: after 6 months
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Bleeding on Probing-BOP 3m
时间窗: after 3 months
assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)
时间窗: baseline measure (before the intervention)
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m
时间窗: after 6 months
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)
时间窗: baseline measure (before the intervention)
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m
时间窗: after 3 months
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m
时间窗: after 3 months
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m
时间窗: after 6 months
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.
Tumor Necrosis Factor Alpha-TNF-α -1m
时间窗: after 1 month
The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Tumor Necrosis Factor Alpha-TNF-α - 3m
时间窗: after 3 months
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.
Matrix Metalloproteinase 8 - MMP-8
时间窗: baseline measure (before the intervention)
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Alkaline Phosphatase - ALP -3m
时间窗: after 3 months
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m
时间窗: after 1 month
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m
时间窗: after 1 month
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m
时间窗: after 1 month
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.
Matrix Metalloproteinase 8 - MMP-8 - 3m
时间窗: after 3 months
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Alkaline Phosphatase - ALP
时间窗: baseline measure (before the intervention)
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Plaque Index- PI -1m
时间窗: after 1 month
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Plaque Index- PI -3m
时间窗: after 3 months
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Plaque Index- PI - 6m
时间窗: after 6 months
visual assessment of plaque index-PI and by probing
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m
时间窗: after 6 months
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m
时间窗: after 6 months
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.
Periodontal Pocket Microorganisms - 6m
时间窗: after 6 months
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.
Alkaline Phosphatase - ALP -1m
时间窗: after 1 month
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Alkaline Phosphatase - ALP -6m
时间窗: after 6 months
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.
Bleeding on Probing-BOP - 6m
时间窗: after 6 months
assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).
Plaque Index- PI
时间窗: baseline measure (before the intervention)
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)
时间窗: baseline measure (before the intervention)
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)
时间窗: baseline measure (before the intervention)
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m
时间窗: after 3 months
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.
Periodontal Pocket Microorganisms
时间窗: baseline measure (before the intervention)
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.
Periodontal Pocket Microorganisms -1m
时间窗: after 1 month
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.
Matrix Metalloproteinase 8 - MMP-8 -1m
时间窗: after 1 month
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.
Matrix Metalloproteinase 8 - MMP-8 - 6m
时间窗: after 6 months
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Tumor Necrosis Factor Alpha-TNF-α -6m
时间窗: after 6 months
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.
次要结局
未报告次要终点
研究者
Natasa Nikolic Jakoba
Associate professor, DDS, MSc, PhD
University of Belgrade