Synergistic effects of Photobiomodulation and Titanium Reinforced Platelet Rich Fibrin in the treatment of Intrabony defects -A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1.Early healing Index(HI) (Wachtel et al.2003)
研究概览
简要总结
Patients reporting to the Department of Periodontics and Implantology, Vishnu Dental College with stage-II and III Grade- B and C Periodontitis as per 2017 classification will be included in the study and they will be randomly assigned to either of the groups. A written informed consent will be obtained from all the patients. Phlebotomy will be perfomed to collect blood of 10 ml to prepare T-PRF.After performing access flap surgery, the site is irradiated with Photobiomodulation followed by placement of T-PRF and suturing will be done. Post operatively the site is again irradiated with PBM in test group patients.In control group following access flap surgery T-PRF is placed and suturing will be done. Healing Index will be assessed after 1week. Clinical Parameters like Probing Depth, Clinical attachment level, Gingival Index, Plaque Index will be assessed at baseline, 3 months and 6 months. Radiological Parameters like Linear amount of bone fill, Percentage bone fill, Depth defect, Defect Angle will be assessed at Baseline and 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.3-walled intrabony defects having a radiological vertical bone loss of greater than or equal to 3mm with a persistent probing depth of greater than or equal to 5mm after non surgical therapy 2.Evidence of greater than or equal to 3mm of Intrabony depth defect 3.Intrabony defect angle of 37-40 degrees.
- •4.Non smokers.
排除标准
- •ASA-III,IV,V Patients undergoing Bis-phosphonate therapy.
结局指标
主要结局
1.Early healing Index(HI) (Wachtel et al.2003)
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
2.Probing pocket depth (PPD) using UNC 15 probe
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
3.Clinical attachment loss (CAL)
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
4.Linear amount of bone fill
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
5.Percentage bone fill
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
6.Defect depth
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
7.Defect angle
时间窗: 1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week | 2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months | 3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months | 4.Linear amount of bone fill-At baseline and 6 months | 5.Percentage bone fill-at baseline and 6 months | 6.Defect depth-at baseline and 6 months | 7.Defect angle-at baseline and 6 months
次要结局
- 1.Plaque index (Silness and Loe,1964)(2.Gingival index(Loe and Silness 1963))