Comparative evaluation of demineralized freeze dried bone allograft with and without PRF membrane in the treatment of periodontal intrabony defects.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- • Changes in PPD (Periodontal Probing Depth)
研究概览
简要总结
Periodontal therapy aims to arrest disease progression and regeneration of structures lost to disease. Periodontal regeneration requires a sequence of cell migration, adherence, growth and differentiation, which have potential to increase regeneration.To be considered a regenerative modality, a material or technique must demonstrate that bone, cementum and a functional periodontal ligament can be formed on a diseased root surface.
Various bone materials such as autogenous grafts, demineralised freeze-dried bone allografts, bovine bone xenografts, or synthetic bone substitutes have demonstrated regenerative potential and have been successfully used in the treatment of intrabony defects. The use of demineralised freeze-dried bone allografts (DFDBA), whether alone or in combination with other treatment modalities for periodontal therapy, has repeatedly demonstrated significant improvements in both soft and hard clinical tissue parameters.Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, periodontal bone grafts show strong potential. A large body of clinical evidence clearly indicates that grafts consistently lead to better bone fill than non-grafted controls. DFDBAs have repeatedly demonstrated significant improvements in soft and hard clinical tissue parameters for the treatment of intraosseous periodontal defects. Substances present in the demineralized bone graft material, i.e., bone morphogenic proteins, stimulate local cell cycles to produce new bone. The freeze drying process destroys cells while maintaining cellular morphology and chemical integrity. These two factors, in conjunction with other materials, enhance periodontal regeneration and/or bone fill.
In periodontology, platelet-rich fibrin (PRF) has become a useful add-on therapy with the goal of accelerating periodontal tissue regeneration and repair. PRF is a concentrated form of platelets, growth factors, and cytokines, an autologous preparation made from the patient’s own blood. Due to its distinctive makeup, PRF can successfully encourage tissue regeneration and healing after a variety of periodontal procedures. It can enhance the results of treatments like guided tissue regeneration and bone grafting by acting as a natural scaffold to assist with the growth of new bone and connective tissue. PRF has been shown to accelerate soft tissue healing, lessen postoperative pain, and reduce swelling and inflammation. Its use in procedures including implant placement, gingival recession coverage, and flap surgeries have demonstrated enhanced wound healing and aesthetic results. The ability of PRF to create an advantageous milieu rich in cytokines and growth factors aids in improving the results of different periodontal procedures.
Therefore, the purpose of this study was to compare clinical and radiographic outcomes obtained with combination of PRF and DFDBA to those obtained with DFDBA alone in treatment of periodontal intrabony 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
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with moderate to severe periodontitis with a probing depth (PD) ≥5mm & Intrabony component of ≥3 mm as detected on IOPA x-ray & bone sounding.
- •2.Healthy individual willing for study with no systemic diseases that will influence the outcome of therapy.
- •3.Not using tobacco in any form.
- •Able to achieve good oral hygiene.
- •Subjects who were available for follow up.
排除标准
- •Medically compromised patients with presence of any systemic disease.
- •Pregnant & Lactating women.
- •Patients taking any medication.
- •Teeth with one wall defects, furcation involvement & mobility.
- •Hypersensitivity or allergy to allograft based medical products.
结局指标
主要结局
• Changes in PPD (Periodontal Probing Depth)
时间窗: Baseline and after 6 months
• CAL (Clinical Attachment Level)
时间窗: Baseline and after 6 months
• Radiographic bone gain
时间窗: Baseline and after 6 months
次要结局
- Changes in position of Gingival margin(Plaque Index)
研究者
Sarita Parihar
Institute of Medical Sciences, Banaras Hindu University
