Evaluation of Hyaluronic Acid in combination with PRF and PRF alone assessed by cone beam computed tomography in the management of intrabony defects: A randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of efficacy of Hyaluronic Acid in combination with PRF in intrabony defects clinically by measuring probing depth, relative attachment loss, plaque index and gingival index.
研究概览
简要总结
Periodontitis is an infectious disease that causes destruction of the toothattachment apparatus. If periodontitis is left untreated it may result in progressive attachment loss that may eventually lead to early tooth loss.1The soft and hard tissue loss occurred as a result of periodontitis, cannot be managed successfully by nonsurgical therapy alone and requires modalities for the regeneration of lost tissues.In halting the progression of periodontitis and maintaining disease related defects conventional periodontal treatments such as scaling, root planning and open flap debridement are highly effective.2For osseous, furcation and recession defects periodontal regenerative procedures are included such as soft tissue grafts, bone replacement grafts, root biomodifications, guided tissue regeneration, and combinations thereof.3Advances in understanding the inflammatory mechanisms and wound healing processes associated with periodontal diseases have led researchers to study the potential of numerous extracellular matrix components as promoters of periodontal healing and regeneration.4Hyaluronic Acid (HA) is one such natural extracellular matrix component, which plays a vital role in the functioning of extracellular matrices, including those of the periodontium. HA significantly increases the tensile strength of granulation tissue, initiates angiogenesis, stimulates clot formation, and augments bone formation.4Through increased mesenchymal cell differentiation and migrationHyaluronic Acid augments osteoblastic bone formation. In the morphologically healing of bone wounds HA provides the potential means for accelerating new bone formation.5There are several growth factors that are used in order for bone healing and bone regeneration. PRF(PLATELET RICH FIBRIN) is an autologous fibrin with abundance of platelets and leukocyte cytokines. PRF contains proportionately highlevels of growth factors, including the platelet-derived growth factor (PDGF), TGF, vascular endothelial growth factor, insulin-like growth factor (IGF), and epidermal growth factor (EGF).In bone grafting or bone defect healing, the growth factors play a centralrole in bone regeneration process and in hemostasis which makes PRFmore advantageous.6 Cone beam computed tomography (CBCT) provides a 3-dimensional (3D) view of the maxillofacial complex. Visualization of periodontal bone defects in 3 dimensions can be valuable because it has been shown that the healing of these defects is highly dependent on defect anatomy. . Therefore, the outcome of the treatment is predicted on an accurate examination of the defect’s anatomy.7To the best of our knowledge no studies have been carried out comparing the use of combination of Hyaluronic Acid + PRF and PRF alone in intrabony defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Systemically healthy patients.
- •Patients with mild to moderate chronic periodontitis with 2 & 3 walled intrabony defects.
- •Full mouth plaque scores should be less than 15%.
排除标准
- •Patients who underwent flap surgery within 1year.
- •Teeth indicated for extraction.
- •Patients having habit of consuming tobacco in any form.
- •Pregnant and lactating women.
- •Patients on any drug therapy which may affect the outcome of present study.
结局指标
主要结局
Evaluation of efficacy of Hyaluronic Acid in combination with PRF in intrabony defects clinically by measuring probing depth, relative attachment loss, plaque index and gingival index.
时间窗: baseline and 6 months
2)To evaluate the radiographic defect fill with the use of Hyaluronic Acid
时间窗: baseline and 6 months
in combination with PRF and PRF alone in intrabony defects
时间窗: baseline and 6 months
by measuring defect depth, mesio-lingual defect width and bucco-lingual defect width.
时间窗: baseline and 6 months
次要结局
- Evaluating the efficacy of Hyaluronic Acid in combination with PRF and PRF alone in intrabony defects, clinically by measuring clinical attachment loss, relative attachment loss, plaque index and gingival index and radiographically by measuring defect depth, mesio-lingual defect depth and bucco-lingual defect depth(baseline and 6 months)
