跳至主要内容
临床试验/CTRI/2021/04/033061
CTRI/2021/04/033061进行中(未招募)不适用

Effectiveness of nano hydroxyapatite graft with or without platelet rich fibrin membrane in the treatment of periodontal intrabony defects.

Dr L Krishna Prasad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月5日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
1) Improvement in clinical attachment level,

研究概览

简要总结

Periodontitis is a progressive inflammatory disease which causes destruction of the periodontal ligament and alveolar bone with pocket formation. The ultimate goal of periodontal therapy is the regeneration of periodontal tissues that have been destroyed due to periodontal disease. Periodontal regeneration is the reconstruction of the lost tissues as evidenced histologically in the formation of new cementum, new alveolar bone, and functionally oriented periodontal ligament.2Loss of alveolar bone support is one of the characteristic signs of destructive periodontal disease and is generally considered to represent the anatomical sequelae to the apical spread of periodontitis. The intrabony defects are associated with the loss of tooth support, relates to the site specificity of the periodontal destruction and to the possibility that ecological niches may represent site specific risk factors or indicators for disease progression. Treatment of bony defects is intended to meet two objectives. Elimination of microbial plaque from exposed surfaces of the root and establishing the anatomy of effected surfaces that facilitates proper self-performed plaque control.Different types of bone grafts are used to fill the periodontal defects and restore the lost periodontal attachment apparatus such as autografts, allografts and alloplastic materials.Alloplasts are synthetic, inorganic, biocompatible and non-antigenic graft substitutes. Eggshell derived hydroxyapatite is hydrophilic in nature, absorbed by body fluids and blood, so that handling becomes easy for placing it in the surgical site. Lack of disease transfer risks, biocompatibility, and ease of use makes it a viable choice as regenerative material. Hydroxyapatite is a naturally occurring mineral component of bone and is osteoconductive in nature. PRF membrane is a second-generation autologous platelet concentrate and is a fibrin mesh consisting of leukocytes and cytokines. It activates the vascular system and angiogenesis and releases growth factors like PDGF, insulin like growth factor, vascular endothelial growth factor, and TGF, which are involved in soft and hard tissue healing. PRF has been utilized for a variety of clinical procedures acting as an autologous barrier membrane for the treatment of intrabony periodontal defects.  PRF has a proliferative effect on different types of cells such as osteoblasts, gingival fibroblasts, and PDL cells. Thus, this homogenous fibrin network is considered as healing biomaterial and is used to enhance bone regeneration. Two dimensional radiographic methods such as IOPA, bitewing radiographs, periapical radiographs and OPG are severely limited by the inherent overlay of anatomic structures and the difficulty to reproduce angles over time. Cone beam computed tomography (CBCT) enables cross-sectional and 3D analysis without distortion and evaluating osseous defects with high resolution. To evaluate the effectiveness of nano hydroxyapatite graft which may help in achieving favorable bone regeneration by promoting healing and platelet rich fibrin membrane when used in combination provides graft stabilization and improves clinical parameters in the intra bony defects.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 20 – 60 years.
  • Intrabony defects in the posterior teeth.
  • Patients with a probing depth of greater than or equal to 5mm.
  • Patients with radiographic evidence of greater than or equal to 3mm distance between alveolar crest and base of defect.

排除标准

  • Presence of any systemic disease.
  • Pregnant and lactating women.
  • Patients who underwent periodontal therapy from the past 6 months.

结局指标

主要结局

1) Improvement in clinical attachment level,

时间窗: Base line and 3 and 6 months

2)Reduction of probing depth

时间窗: Base line and 3 and 6 months

3)Bone regeneration

时间窗: Base line and 3 and 6 months

次要结局

  • Increased Stability of tooth and function(Base line and 3 and 6 months)

研究者

发起方
Dr L Krishna Prasad
申办方类型
Research institution and hospital

研究点 (1)

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