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临床试验/CTRI/2026/01/100355
CTRI/2026/01/100355尚未招募不适用

Comparative Clinical and Radiographic Evaluation of Xenograft, Xenograft with Injectable Platelet-Rich Fibrin and Xenograft with Injectable Platelet-Rich Fibrin and Hyaluronic Acid (0.2 percent) in Periodontal Intrabony Defects: a randomised control trial

Dr Sushmita Tiwari1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1

研究概览

简要总结

Periodontitis is a chronic inflammatory disease characterized by the destruction of the supporting structures of the teeth including the periodontal ligament alveolar bone and gingiva

It results from a complex interplay of microbial infection and host immune response leading to progressive attachment loss and bone resorption. If left untreated periodontitis can cause tooth mobility and eventual tooth loss significantly impacting oral health and quality of life

One of the hallmark manifestations of periodontitis is the formation of periodontal intrabony defects where the alveolar bone loss creates vertical defects within the bone surrounding the tooth roots. These intrabony defects are challenging to manage due to their complex anatomy and the goal of regenerating the lost bone and periodontal ligament Effective management of these defects is critical to halt disease progression and restore periodontal health

Open flap debridement  is a common surgical procedure used to treat intrabony defects. It involves reflecting a full thickness mucoperiosteal flap to gain direct access to the root surfaces and defect area allowing thorough debridement of granulation tissue and calculus.Although Open flap debridement helps reduce pocket depth and inflammation it has limited potential to regenerate lost periodontal tissues on its own prompting the use of adjunct regenerative materials to enhance healing outcomes

Bone grafts especially Xenografts have long been considered a standard approach for periodontal regeneration owing to their osteoconductive properties ability to maintain space and predictable bone fill. These materials provide a matrix that facilitates cell migration and vascularization promoting bone regeneration with good biocompatibility and long term stability. However regenerative outcomes can be further enhanced by combining grafts with biologically active materials. Platelet rich fibrin  and particularly its injectable form has emerged as a potent adjunct in periodontal therapy

Platelet rich fibrin is an autologous platelet concentrate that contains a high concentration of growth factors which stimulate angiogenesis fibroblast proliferation and osteoblastic activity

Platelet rich fibrin also provides a fibrin matrix that acts as a scaffold for cell migration supporting both soft and hard tissue regeneration

Its ease of preparation cost effectiveness and minimal risk of immunogenic reaction make it a widely used adjunct in periodontal therapy

Injectable platelet rich fibrin  is a newer liquid form of Platelet rich fibrin that retains the same biologically active components while offering enhanced handling properties

Unlike conventional Platelet rich fibrin and injectable Platelet rich fibrin can be easily mixed with graft materials and injected into defect sites ensuring intimate contact with the surrounding tissues This promotes better growth factor delivery  improves angiogenesis  and accelerates tissue healing making injectable Platelet rich fibrin particularly suitable for minimally invasive regenerative procedures

Another promising adjunct is Hyaluronic acid  is a naturally occurring glycosaminoglycan present in the extracellular matrix that plays a key role in wound healing, inflammation modulation and tissue hydration

Hyaluronic acid exhibits anti inflammatory properties and promotes fibroblast proliferation and angiogenesis making it a promising adjunct in periodontal regeneration

Its application in intrabony defects has shown to improve clinical outcomes by supporting tissue repair and reducing post surgical discomfort

While each of these regenerative materials has demonstrated individual efficacy there remains a paucity of evidence directly comparing the volumetric regenerative outcomes of xenografts combined with injectable platelet rich fibrin and Hyaluronic acid in the treatment of intrabony defects.

Various methods have been adopted for pre and postsurgical evaluation of the periodontal treatment including clinical probing conventional radiographs surgical reentry and histologic examination However most of these methods failed to evaluate the exact morphology of the periodontal tissues The advent of cone beam computed tomography enabled clinicians to precisely identify the three dimensional morphology of the osseous defects along with volumetric assessment of healing periodontal tissues Effectiveness of the surgical procedure and material used have been assessed in periodontal research by various means CBCT is one of the noninvasive methods where the volumetric assessment of the bone defect can be done and its application provides significant aid for better understanding of the furcation defects.

Thus aim of present study is to compare clinical and radiographic evaluation of xenograft xenograft with injectable platelet rich fibrin and xenograft with injectable platelet rich fibrin and  hyaluronic acid in periodontal intrabony defects at baseline and 6 months follow up

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from stage III periodontitis with grade A or B.
  • Patients to have atleast one intrabony 2 or 3 wall defect in upper and lower posteriors with PPD greater or equal to 6mm , CAL greater or equal to 6 mm and an intrabony component greater or equal to 3 mm measured on digital periapical radiograph.
  • Vital teeth with properly performed endodontic treatment.
  • Plaque control instructions will be repeated until patients achieved a full mouth plaque score less than 20% and gingival index score less than 20%.

排除标准

  • Patients with aggressive periodontitis.
  • Known allergy to any of the materials Chronic smokers Patients with hypertension, diabetes or any other systemic disorders which affect the outcome of the treatment.
  • Patients with bleeding and coagulation disorders Pregnant and lactating mothers.
  • Having undergone surgical periodontal therapy in last 6 months.

研究者

发起方
Dr Sushmita Tiwari
申办方类型
Other [self funded ]
责任方
Principal Investigator
主要研究者

Dr Sushmita Tiwari

Manipal College of Dental Sciences Mangalore

研究点 (1)

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