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临床试验/NCT07049549
NCT07049549已完成不适用

Evaluation of the Effectiveness of Adjunctive Injectable Platelet-Rich Fibrin Application to Root Surface Debridement in Phase 1 Treatment of Smoking Patients With Periodontitis

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
The evaluation of changes in Probing Pocket Depth (PPD)

研究概览

简要总结

Periodontitis is a chronic, multifactorial inflammatory disease characterized by the progressive destruction of the tissues supporting the teeth, associated with dysbiotic plaque biofilms. The foundation of non-surgical periodontal treatment is the mechanical debridement of the tooth surfaces to reduce bacterial load. In this phase, dental calculus and bacterial deposits are removed, and root surfaces are smoothened. This helps eliminate the microorganisms responsible for inflammation. Following treatment, epithelial healing occurs in the form of long epithelial attachment, which re-forms within approximately one week. The reduction of inflammatory cells, tissue repair, and decreased gingival crevicular fluid flow lead to the resolution of clinical signs such as redness and swelling. A tissue recession of 1-2 mm is generally observed. The fibrils in the connective tissue are altered or lysed during the disease process, and their reorganization and healing may take several weeks.

The aim of this study is to evaluate the clinical effects (plaque index, gingival index, bleeding on probing, probing pocket depth, clinical attachment level) of injectable platelet-rich fibrin (I-PRF) in addition to non-surgical periodontal treatment in periodontitis patients with deep pockets and smoking habits.

In advanced cases, surgical treatments may be required. According to the study by Heitz-Mayfield and colleagues, surgical treatment in pockets deeper than 6 mm resulted in a 0.6 mm greater reduction in probing depth and 0.2 mm more clinical attachment gain compared to scaling and root planing alone. However, for pockets between 4-6 mm in depth, non-surgical treatment resulted in 0.4 mm more attachment gain compared to surgical procedures. In a systematic review by Labriola and colleagues, it was found that smokers had a lesser reduction in pocket depth. Furthermore, Scabbia and colleagues reported that smokers had significantly lower clinical improvements after surgical treatment. Smoking negatively affects healing, and factors such as exposed root surfaces and protected areas for residual plaque contribute to disease recurrence. Long-term studies have shown that smokers experience higher tooth loss.

The use of blood-derived products in wound healing started 40 years ago, with fibrin adhesives standing out. Fibrin is the activated form of fibrinogen, a plasma molecule, and is the final product of coagulation. Polymerized fibrin forms the initial scar matrix in the wound area, serving as a biological adhesive that aids in hemostasis.

One of the most commonly used blood-derived products in dentistry is platelet-rich fibrin (PRF). Developed by Choukroun in 2001, this second-generation product can be prepared without anticoagulants, thrombin, or gelling agents. It is a simple and cost-effective method. Injectable PRF (I-PRF) is obtained by altering the centrifugation speed and duration. Miron and colleagues demonstrated that low-speed I-PRF contains a higher number of regenerative cells and growth factors. A study by Kour and colleagues showed that I-PRF has antimicrobial effects against periodontal pathogens such as Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans.

In conclusion, I-PRF, prepared from the patient's own blood, may provide biological support to non-surgical periodontal treatment, positively influencing the healing process and reducing the need for surgical interventions. The aim of this study is to assess the clinical effects (plaque index, gingival index, bleeding on probing, pocket depth, clinical attachment level) of I-PRF in conjunction with non-surgical periodontal treatment in periodontitis patients with deep pockets and smoking habits.

A total of 25 volunteers will be included in the study. Inclusion criteria are: not pregnant, no use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids, no periodontal treatment in the past 6 months, presence of at least 20 teeth, bleeding on probing in ≥30% of sites, and at least two non-adjacent teeth in each quadrant with probing depth ≥5 mm, clinical attachment loss ≥4 mm, and radiographic evidence of bone loss in the coronal third (horizontal and/or vertical). Informed consent will be obtained after explaining the study.

Eligible participants will undergo clinical periodontal evaluation including plaque index (Silness & Löe, 1964), gingival index (Löe & Silness, 1963), probing depth, clinical attachment loss, and bleeding on probing (Ainamo & Bay, 1975). At the second visit, full-mouth scaling and root planing will be performed. In the test sites, injectable platelet-rich fibrin (I-PRF), prepared by centrifugation at 700 rpm for 3 minutes, will be applied. Control sites will receive saline without antimicrobial or regenerative effects. Follow-ups for oral hygiene reinforcement will be scheduled at 1 week, 1 month, and 3 months. Clinical measurements will be repeated at 3 months.

详细描述

Periodontitis is a chronic, multifactorial inflammatory disease characterized by the progressive destruction of tooth-supporting tissues associated with dysbiotic plaque biofilms. The loss of periodontal support manifests clinically as attachment loss, alveolar bone loss, periodontal pocket formation, and gingival bleeding. Due to its high prevalence, potential to cause tooth loss, negative impact on chewing function and esthetics, and reduction in quality of life, periodontitis is considered a significant public health concern. The primary etiological factor of the disease is microbial plaque and its byproducts.

The goal of periodontal treatment is to halt disease progression by controlling the microbial etiology and associated risk factors and to restore lost periodontal structures, thus maintaining a functional and esthetically acceptable dentition. Various treatment modalities have been developed to reduce bacterial plaque on root surfaces. Conventional methods include mechanical plaque removal using hand instruments and ultrasonic devices, with scaling and root planing considered the gold standard in periodontal therapy.

Adjunctive use of local agents with root surface debridement has shown additional benefits. These agents help reduce bacterial contamination and promote healing. Local antimicrobial agents suppress subgingival microbiota and support the control of inflammation. Other materials, such as hyaluronic acid and statins, have also demonstrated beneficial clinical outcomes when used in conjunction with non-surgical periodontal therapy.

Smoking is a major risk factor both for the onset of periodontitis and for a reduced treatment response. Smokers tend to exhibit less favorable healing after non-surgical treatments and experience greater tooth loss over time. Additionally, smoking can result in exposed root surfaces and protected areas that facilitate plaque accumulation, contributing to disease recurrence.

Platelets have gained attention in regenerative therapies due to their ease of collection and their rich content of growth factors. Platelet-derived factors such as TGF-β1 exhibit both pro- and anti-inflammatory properties. Platelets become activated following endothelial injury and, through various adhesion molecules, initiate inflammatory responses and support tissue repair. They also play a key role in hemostasis and wound healing by stimulating fibroblast, endothelial, and progenitor cell activity through their released growth factors.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 70 years
  • Having at least 20 natural teeth
  • Presence of interproximal CAL and/or buccal or lingual CAL ≥3 mm accompanied by PPD >3 mm in at least two non-adjacent teeth
  • Presence of periodontal pockets ≥4 mm in at least one site in each dental arch
  • Smoking more than 10 cigarettes per day
  • Absence of systemic diseases or ongoing medication use
  • No antibiotic, anti-inflammatory, or systemic corticosteroid use within the last 6 months
  • No periodontal treatment within the last 6 months
  • Not pregnant, lactating, or menstruating

排除标准

  • presence of systemic or oral diseases
  • regular systemic medication use
  • recent periodontal or pharmacological treatment history
  • hormonal conditions.

研究组 & 干预措施

Test Group

Active Comparator

Subjects would receive full-mouth scaling and root planing (SRP). Following instrumentation, autologous injectable platelet-rich fibrin (i-PRF) will be prepared from venous blood and administered subgingivally to the test quadrants according to a split-mouth design.

干预措施: Injectable PRF (Biological)

Control Group

Placebo Comparator

Subjects will be receive full-mouth scaling and root planing (SRP). Following instrumentation, placebo (sterile saline) is administered subgingivally to the control quadrants according to a split-mouth design.

干预措施: Plasebo (Sterile Saline) (Other)

结局指标

主要结局

The evaluation of changes in Probing Pocket Depth (PPD)

时间窗: Baseline and 3 months

Probing Pocket Depth (PPD) measurements are take at baseline (first session) and at the 3-month follow-up to assess clinical changes over time. Using a periodontal probe, the distance between the gingival margin and the base of the sulcus or periodontal pocket is measured at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, midpalatal/lingual, and distopalatal/lingual. Care is taken to keep the probe parallel to the long axis of the tooth and to apply minimal force during measurement. The values from the six sites are summed and divided by six to calculate the average PPD.

The evaluation of changes in Clinical Attachment Levels (CAL)

时间窗: Baseline and 3 months

CAL measurements are taken at baseline (first session) and at the 3-month follow-up to assess clinical changes over time. Using a periodontal probe, the distance between the enamel-cement junction and the base of the sulcus or periodontal pocket is measured at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, midpalatal/lingual, and distopalatal/lingual. The values from these six points are summed and divided by six to calculate the average clinical attachment level.

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tolga Sönmez

research assistant

Izmir Katip Celebi University

研究点 (1)

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