Comparative Study of Advance Platelet Rich Fibrin/Concentrated Growth Factor Technology in Regenerative Periodontal Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- CAL (clinical attachment level)
研究概览
简要总结
Guided tissue regeneration(GTR) uses membranous materials to shield gingival epithelial cells and connective tissue cells which grow more rapidly, creating an effective closed space and time for periodontal ligament cells with regenerative potential, so that new cementum is formed on the root surface and periodontal ligament fibers are embedded, resulting in regenerative healing. In order to improve the effect of periodontal regeneration therapy, as early as 1990s, scholars began to mix platelet concentrate and bone graft in periodontal regenerative surgery to improve the ability of local bone induction and tissue healing. Studies have shown that platelet concentrate, which is rich in a variety of growth factors in autologous blood, can promote soft tissue and bone tissue healing by acting on tissue healing cells (osteoblasts, epithelial cells, connective tissue cells, etc.). It is closely related to periodontal regeneration; the regenerative component of platelet concentrate, growth factor, and the structure of fibrin network containing growth factor are the key to promote tissue repair and regeneration.Modified platelet-rich fibrin (advanced platelet rich fibrin,APRF) and concentrated growth factor (CGF) are the latest generation of platelet concentrates. A number of studies have shown that APRF and CGF contain more cytokines, have a denser fibrin network, and show stronger ability to promote the migration and proliferation of gingival fibroblasts, suggesting that both of them may have better ability to promote bone tissue healing. At present, the latest generation of platelet concentrate has been widely used in implant surgery, but their clinical effects in periodontal regeneration surgery are still lack of conclusive evidence. there is no report on comparing the clinical effects of the two through randomized clinical controlled trials.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Researcher B is responsible for including the subjects and assigning the number of the subjects according to the order of treatment. During the operation, researcher B will give the sealed envelope to the surgeon L according to the number, then leave, and will not participate in surgery, measurement and other studies. Researcher C is responsible for measuring various indicators on a regular basis. Until the end of the experiment, C did not know the grouping of the subjects.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patient is 18-80 years old.
- •selection of affected teeth: there is still at least one site of periodontal probing depth ((PD) ≥ 5mm) at 6-8 weeks after initial periodontal treatment,and the degree of mobility is less than grade II or II-III degree but without mobility after fixation.Imaging evaluation shows that the tooth has a Intrabony defect which is larger than 3mm, and there is no history of periodontal surgery at this site, and the affected tooth has no obvious symptoms of discomfort.
- •The patient has good compliance, good plaque control after basic treatment (bleeding index and plaque index < 20%). He/She can understand the purpose of the test and is willing to cooperate with surgical treatment and follow-up. He/She voluntarily participates in the trial and signs informed consent.
排除标准
- •In the past 6 months, patients who chewed smokeless tobacco, smoked a pipe or cigar once a week, or smoked more than 20 cigarettes per week (1 pack per week);
- •Patients took any drug affecting platelet function or had a platelet count less than 200000/mm3 3 months before blood collection.
- •Patients have taken antiepileptic drugs, antihistamines, antidepressants, sedatives, sedatives, anti-inflammatory drugs or daily analgesics within 1 month before operation;
- •Patients with a history of diabetes or patients with abnormal blood glucose test (fasting blood glucose ≥ 7mmol/L);
- •Liver and renal dysfunction (AST, ALT ≥ 1.5 times ULN, creatinine ≥ 1.5 times ULN);
- •Patients with severe endocrine and metabolic diseases.
- •Those with a history of grade 3 hypertension;
- •Those with a history of osteoporosis;
- •Those with a history of autoimmune diseases;
- •Those with a history of malignant tumor or other serious diseases who are not suitable for surgery or cause observation of tooth loss;
- •Pregnant or lactating women;
- •Patients with local anesthetic allergy.
- •Clinical or radiological findings showed acute infection, apical lesions, root fractures, severe root deformities, cementum beads, indelible enamel protuberances, untreated caries at the enamel or root boundary, and restoration reaching subgingival and/or below CEJ or marginal incongruity
- •All kinds of subjects who can cause artifacts in oral imaging examination, such as: the study teeth and their adjacent teeth are metal dentures and porcelain teeth;
- •The affected teeth have root furcation lesions
结局指标
主要结局
CAL (clinical attachment level)
时间窗: Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)
The distance from periodontal pocket bottom to CEJ was measured by periodontal probe (mm). Record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ).In order to ensure the operability and scientificity of follow-up, it is defined as follows.
次要结局
- PD（probe depth）(Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- BOP(bleeding of probe)(Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- IC(Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- Defect fill (%)(Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- mobility(Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- regenerated bone volume parameters(Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- Defect resolution (%)(Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))
- RBL（adiographic bone level）(Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3))