A Comparative Evaluation of Effectiveness of Concentrated Growth Factor (CGF) and Platelet rich fibrin (PRF) alone in the Treatment of Human Infrabony Defects– A Clinical and Radiographic Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
Various graft materials have been successfullyused in the treatment of intrabony defects. The materials most commonly usedhave been autografts and allografts. Growth factors are bioactive proteinswhich regulate a variety of cellular processes. Concentrated Growth Factors(CGF) was first developed by Sacco (2006), is a relatively new technologywithin the area of regenerative medicine. CGF is an advanced second generationplatelet concentrate, obtained with differential continuous centrifugaltechnology, containing many kinds of growth factors and fibrins, and able tofacilitate the recovery of soft and hard tissues. CGF is different fromplatelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in the methods forproduction because no additives are added during its production. CGF has ahigher adhesive strength, tensile strength, higher viscosity than the otherplatelet preparations. CGF has a difference in centrifugation speed whichpermits the isolation of much larger and denser fibrin matrix richer in growthfactors. CGF is a fibrin rich organic matrix which contains growth factors,platelets, leukocytes and CD34+ stem cells which help in the process ofregeneration and also has immunological cells that are effective in regulatinginflammation and minimizing the risk of infection. (CGF) is a biologicalinducing material which improves the quality of the formed bone, andfacilitates the formation of bones and the healing of tissues.
Therefore, the present study will be undertaken to evaluate theeffectiveness of Concentrated growth factor and PRF alone for the treatment ofinfrabony defects in humans
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of at least 1 or 2 radiographically detectable interproximal intrabony osseous defect with probing pocket depth ≥ 5 mm and clinical attachment loss ≥ 5 mm following initial therapy.
- •2.Depth of intraosseous component of the defect ≥ 3 mm by clinical and radiographic means, which will be confirmed on intrasurgical measurment 3.A radiographic base of the defect at least 3 mm coronal to the apex of the tooth.
- •Presence of at least 3 mm width of keratinized gingiva around test teeth to allow complete soft tissue coverage of the defect.
排除标准
- •1.Evidence of localized aggressive periodontitis.
- •2.Patients with unacceptable oral hygiene (Plaque Index >1) 3.Smokers (recent history of smoking more than 10 cigarettes /day) or who used any of tobacco products.
- •4.Study tooth with inadequate endodontic / restorative treatments.
- •5.Study tooth with mobility exceeding grade II and exhibiting a class III or class IV furcation defect.
- •6.History of periodontal surgical therapy of the selected quadrant.
- •7.Pregnant females or lactating mothers.
- •8.Clinical or radiographic signs of untreated acute infection at the selected site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel projections not easily removed by odontoplasty, untreated carious lesions at cementoenamel junction (CEJ) or on the root surface.
结局指标
主要结局
Probing Pocket Depth
时间窗: baseline, 3 months, 6 months, 9 months
Clinical Attachment Level
时间窗: baseline, 3 months, 6 months, 9 months
次要结局
- Periodontal health(baseline, 3 months, 6 months, 9 months)