跳至主要内容
临床试验/CTRI/2021/07/035226
CTRI/2021/07/035226尚未招募不适用

"Comparison of the effectiveness of demineralized freeze dried bone allograft and titanium-prepared platelet rich fibrin in treating intra-bonydefects under surgical operating microscope A Randomized split mouth study"

N Hari Priya1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年8月20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
28
试验地点
1
主要终点
To evaluate the effectiveness of T- PRF in treating intra-bony defects based on clinical and radiographic parameters

研究概览

简要总结

Periodontitis is an infectious disease of the supporting structures of the teeth

in which changes occurring within the alveolar bone are very crucial because

the destruction of the bone is responsible for mobility and tooth loss. The

resorption process of bone is usually interfered by various factors such as

severe gingival inflammation, changes within the bacterial plaque composition,

continuous or repeated trauma to the tooth by occlusal discrepancies and

systemic diseases.

One way of determining whether an inflammatory gingival lesion has

spread into the underlying periodontal structures is by radiographic evidence

of crestal alveolar bone loss and associated pocket formation. It is often

characterized by formation of intra-bony defects and the treatment of these

defects still remains a challenge to the clinician. Several regenerative

procedures have been described in the literature.

Graft material used for periodontal regeneration are categorized as autografts,

allografts, xenografts. Autografts and DFDBA have histologic evidence of pdl

regeneration in humans. Harvesting intraoral autogenous bone for pdl grafting is

often an unattractive option due to the limited quantity of bone available as well

as potential need for second surgical site. where as Decalcified freeze-dried

bone allograft (DFDBA) contains bone morphogenetic proteins (BMPs) that aid

in mesenchymal cell migration, attachment and osteogenesis have both

osteoinductive as well as osteoconductive activity and the ability to create and

maintain the space. DFDBA has been proposed as an effective regenerative

material for osseous defects.

Later on, research efforts shifted toward platelet concentrates because of the

acceleration of wound healing and stimulation of adjacent cells for the

restoration of the lost periodontium.

Platelet concentrates are way ahead of other biomaterials due to constant

release of growth factors over a time period, which are crucial for stimulation

of adjacent progenitor cells, leading to periodontal regeneration and tissue

healing.5 These platelet concentrates also have leucocytes, vitronectin,

fibronectin, bone morphogenetic proteins (BMPs), and cytokines that

contribute to different stages of the wound healing process.6 Initially, platelet-

rich plasma (PRP) was used alone or with bone graft in the treatment of intra-

bony defects. Although the results were reasonable, due to the risk of

antigenicity as a result of the addition of bovine anti-thrombin, leucocyte-

platelet-rich fibrin (L-PRF) was introduced, which does not require any kind of

anticoagulant.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Presence of at least one tooth either on bilateral sides of the mouth with persistent probing depth (PD) ≥ 5mm.
  • Radiographic evidence of intra-bony defects either on bilateral sides of the mouth with depth ≥ 3mm.

排除标准

  • Patients with uncontrolled systemic diseases.
  • Patient who have underwent periodontal procedure 6 months prior.
  • Pregnant or lactating women.
  • Chronic smokers.
  • Patient with grade III tooth mobility Patient with furcation involvement of grade II or more.
  • Patient with trauma from occlusion.

结局指标

主要结局

To evaluate the effectiveness of T- PRF in treating intra-bony defects based on clinical and radiographic parameters

时间窗: CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery

To evaluate the effectiveness of DFDBA in treating intra-bony defects based on clinical and radiographic parameters

时间窗: CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery

To compare the effectiveness of T-PRF versus DFDBA in

时间窗: CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery

treating intra-bony defects based on clinical and radiographic parameters

时间窗: CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery

次要结局

  • Amount of bone fill(Defect depth)

研究者

发起方
N Hari Priya
申办方类型
Other [self]

研究点 (1)

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