Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects: A Randomized Clinical Tria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Clinical attachment level (CAL) gain change from baseline to 12 months
研究概览
简要总结
The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis.
详细描述
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective surgical approaches that help in treatment of periodontal intrabony defects.Due to the shortcomings of access flap approaches , another minimally invasive surgical technique which is the Entire papilla preservation technique will be used to approach the defect .Also, due to the short comings of using other bone substitute materials and resorbable membranes , the Autogenous bone graft which is the gold standard of bone grafts and the injectable platelet rich fibrin will be used in this study .
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
I. Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the operator and patient is not applicable.
- Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with healthy systemic condition.
- •Adult patients (18 years old and older).
- •Patients with stage lll periodontitis, having one isolated intrabony defect with probing depth >6mm, clinical attachment level> 6mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth.
- •Patients with full mouth plaque score<20%.
- •Patients with full mouth bleeding score<20%.
- •Compliance with good oral hygiene.
- •Patients accept 6-months follow-up period (cooperative patients).
- •Patients provide an informed consent.
排除标准
- •Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- •One wall intrabony defect.
- •Defects that involve the buccal and lingual sites.
- •Smokers ˃ 10 cigarettes / day.
- •Pregnant and lactating females.
结局指标
主要结局
Clinical attachment level (CAL) gain change from baseline to 12 months
时间窗: CAL gain will be taken at baseline, 3 month, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner.]
The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.
次要结局
- Linear bone fill change from baseline to 12 months(Linear bone fill will be measured at baseline, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner])
研究者
Laila Taher Sedeek Mohamed
Dr
Cairo University