"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"
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)
