Evaluation of Intrabony Defects treated with Advanced and Titianium enriched Platelet Rich Fibrin. An In Vivo Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- •To evaluate and compare clinical and radiographic outcome of Advanced Platelet - rich fibrin (A-PRF + bone graft) and Titanium Platelet-rich fibrin (T PRF + bone graft) in the treatment of intrabony defect resulting from periodontal disease.
研究概览
简要总结
Thepresent study has been designed as a prospective controlled clinical trial. Thestudy will include suitable number of patients referred for treatment ofchronic periodontitis to the Department of Periodontology, Institute of DentalSciences, Bareilly.
Allparticipants will be informed about the risks and benefits of the procedure andsigned informed consent were taken from them.
Clinicalparameters and radiographic parameters will be recorded at different points oftime i.e. at baseline, 3 months and 6 months.
After recording clinical parameters and administeringphase-1 therapy, the site will be decided by tossing the coin and treatedeither with A-PRF or T-PRF along with bone graftafter raising a full thicknessflap and debridement.
GroupA: Flap surgery with A- PRF + Hydroxyapatite and Tricalcium phosphate (TCP)
GroupB: Flap surgery with T- PRF+ Hydroxyapatite and Tricalcium phosphate (TCP)
TheA-PRF is made in a glass tube as per procedures by Kobayashi et al (2014).
TheT-PRF is made in a titanium test tube that is of medical grade titanium as perprocedures by Mustafa Tunali et al (2011).
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
- 20.00 Day(s) 至 55.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients having minimum of 20 permanent teeth.
- •Age group of 20 to 55 years.
- •Probing pocket depth ≥ 5mm.
- •Clinical attachment loss ≥3mm.
- •Radiographic evidence of intrabony defect.
排除标准
- •Systemically compromised patients.
- •Patients who are on medications that could interfere with wound healing.
- •Patients with grade III mobility.
- •Chronic smokers and alcoholics.
- •Pregnant and lactating females.
- •Patients who had undergone periodontal treatment with in a period of last 1 year.
结局指标
主要结局
•To evaluate and compare clinical and radiographic outcome of Advanced Platelet - rich fibrin (A-PRF + bone graft) and Titanium Platelet-rich fibrin (T PRF + bone graft) in the treatment of intrabony defect resulting from periodontal disease.
时间窗: 6 months
次要结局
- To evaluate the clinical and radiographic outcome after performing periodontal regenerative therapy with A-PRF(To evaluate the clinical and radiographic outcome after performing periodontal regenerative therapy with T-PRF)