Comparative Clinical and Radiographic Evaluation of the Efficacy of Bovine Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF plus) and Bovine Derived Xenograft (Fix-Ossâ„¢) with Injectable Platelet Rich Fibrin (i-PRF) Used in the Treatment of Intrabony Defects in Chronic Periodontitis Patients- A Randomized Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1) Plaque Index (P.I)
研究概览
简要总结
Aim and Objective:
To evaluate and compare clinically and radiographically efficacy of Bovine Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF+) and Bovine Derived Xenograft (Fix-Oss â„¢) with Injectable Platelet Rich Fibrin (i-PRF) when used in the treatment of Intrabony Defects in Chronic Periodontitis Patients.
Material and Methods:
Forty-four intabony defects were randomly allocated to two different groups and were treated with group A (Bovine Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF+) and group B ( Bovine Derived Xenograft (Fix-Oss â„¢) with Injectable Platelet Rich Fibrin (i-PRF).Clinical Parameters such as Plaque Index (P.I.), Gingival Index (G.I.) ,Probing Pocket Depth (PPD) , Clinical Attachment Level (CAL) were recorded at baseline 1 month ,3 months post- surgery, and 6 months post-surgery. Radiographic parameter such as percentage in bone fill (%BF) were calculated by using computerized image analysis software.
Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.
Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.
For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used.
Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test or a suitable test like Fisher’s exact test / McNemar test based on the data obtained.
Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used.
Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group between 30-60 yrs.
- •patients diagnosed with Chronic Periodontitis.
- •Patients who are non smokers or do not consume tobacco in any other form.
- •Patients are in good systemic health with no contraindication to periodontal surgery.
- •Patients having pocket depths >5mm, intraosseous defects > 3mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
- •Involved teeth to be vital and asymptomatic.
排除标准
- •One-walled osseous defects.
- •Patients suffering from any systemic diseases or with a compromised immune system.
- •Patients who had received any type of periodontal therapy for the past 6 months.
- •Patients taking immunosuppressant drugs like corticosteroids.
- •Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
- •Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.
- •Pregnant and/or lactating mothers.
结局指标
主要结局
1) Plaque Index (P.I)
时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month | 4) After 6 month
Tureskey-Gilmore-Glickman Modification of Quigley Hein)
时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month | 4) After 6 month
2.Gingival Index (G.I) (Loe and Sillness,1963)
时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month | 4) After 6 month
3.Probing Pocket Depth (PPD)
时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month | 4) After 6 month
4.Clinical Attachment Level (CAL)
时间窗: 1) At Baseline | 2) After 1 month | 3) After 3 month | 4) After 6 month
次要结局
- The radiographic bone fill will be evaluated using Intraoral Periapical Radiographs of the surgical site.(Baseline- at baseline,immediately after the surgery and 6 months post surgery)