“Comparative Clinical and Radiographic Evaluation of the Effectiveness of Bovine Derived Xenograft (OsseograftTM/DMBM) Alone and a Combination of Bovine Derived Xenograft and Autologous Advanced PRF (A-PRF+) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients –A Randomized Clinical Trial.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Plaque Index (P.I.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein).
研究概览
简要总结
| Aims and objectives : |
To compare and evaluate the effectiveness of Autologous Advanced PRF(A-PRF) with or without Bovine Derived Xenograft (Osseograft TM) in the treatment of intrabony defects in Chronic Periodontitis patients based on cliinical and radiographic parameters.
Materials and methods:
Fourty intrabony defects in which 40 patients were randomly divided into two different groups and were treated with group A (Ossegraft alone) and group B (Osseograft with A-PRF). Clinical parameters such as plaque index (PI), gingival index (GI), pocket probing depth (PPD), clinical attachment level (CAL) were assessed at baseline 1 month, 3 month and 6 month postoperatively; radiographic parameter such as percentage in bone fill (%BF) were calculated by using the computerized image analysis software.
| Data collected will be entered into a computer and analyzed using the SPSS (Statistical Package for the Social Sciences) software. Results on continuous measurements will be presented on Mean ± SD and results on categorical measurements will be presented in Number (%). |
Chi square analysis will be used to find the significance of study parameters on categorical scale. Student t test (two tailed, independent) will be used to find the significance of study parameters on continuous scale within and between two groups (Intra and Inter group analysis) on metric parameters.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient in the age group between 30-60 years.
- •Patient who are non smokers and do not consume tobacco in any form.
- •Patients in good systemic health with no contraindications to periodontal surgery.
- •Patients having pocket depth greater than 5mm, intraosseous defects greater than 3mm with radiographic evidence of vertical or angular bone loss in the affected sites.
- •Involved teeth should be vital and asymptomatic.
排除标准
- •1.) One-walled osseous defects.
- •Patients suffering from any systemic diseases judge to impair normal healing and immune-compromised patients.
- •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.
- •Pregnant or lactating mothers.
- •Patients who were smokers or had tobacco in any other form.
- •Patients on anticoagulant therapy.
结局指标
主要结局
1. Plaque Index (P.I.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein).
时间窗: At Baseline | After 1 month | After 3 month | After 6 month
2. Gingival Index (G.I.) (Loe and Silness, 1963)
时间窗: At Baseline | After 1 month | After 3 month | After 6 month
4. Clinical Attachment Level (CAL)
时间窗: At Baseline | After 1 month | After 3 month | After 6 month
3. Probing Pocket Depth (PPD)
时间窗: At Baseline | After 1 month | After 3 month | 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 month post-surgery)