Comparison of Efficacy of Autologous Platelet - Rich Plasma Combined With Demineralized Freeze - Dried Bone Allograft Versus Demineralized Freeze - Dried Bone Allograft: A Randomized Clinical Trial in Central India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Defect resolution from baseline to 12 months
研究概览
简要总结
The purpose of this clinical trial is to compare the results in subjects with periodontitis using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material, namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment of bone defects around the teeth.
详细描述
After being informed about the study and potential risks, 13 patients giving written informed consent and who meet the eligibility requirements were randomly allocated in a single blind manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).
33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and radiographic outcomes obtained in test and control groups,12 months post - operatively.
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 (Participant)
入排标准
- 年龄范围
- 28 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •with chronic periodontitis
- •who were free of local or systemic disease
- •who had not received any type of periodontal therapy in the last six months
- •radiograph showing at least one angular defect in any quadrant
- •the involved teeth were vital and asymptomatic
- •the site of interest had at least 2 mm of keratinized gingiva on the facial aspect of the selected teeth
排除标准
- •Patients with abnormal platelet count
- •allergic to chlorhexidine or any other medicine used in the study
- •showing unacceptable oral hygiene compliance during / after the phase I therapy;
- •pregnant or lactating mothers;
- •endodontically involved teeth
- •patients under any medication known to interfere with periodontal healing. e.g., corticosteroids
- •on anticoagulant therapy
- •patients with transferable jobs or who were uncooperative
- •patients participating in other dental clinical trials.
结局指标
主要结局
Change in Defect resolution from baseline to 12 months
时间窗: baseline to 12 months
Defect resolution is the distance from the Alveolar Crest to Base of the Defect (AC - BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
Change in Crestal bone resorption from baseline to 12 months
时间窗: baseline to 12 months
Crestal bone resorption is the distance from Cementoenamel Junction to the Alveolar Crest (CEJ- AC); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
Change in Gingival Recession (GR) from baseline to 12 months
时间窗: baseline to 12 months
GR is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the gingival margin measured to the nearest millimeter using UNC-15 probe
Change in Defect fill from baseline to 12 months
时间窗: baseline to 12 months
Defect fill is the distance from Cementoenamel Junction to Base of the Defect (CEJ- BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
Change in Probing Pocket Depth (PPD) from baseline to 12 months
时间窗: baseline to 12 months
PPD is vertical measurement from the free gingival margin to the base of the pocket measured to the nearest millimeter using a UNC (University of North Carolina) -15 periodontal probe.
Change in Periodontal Attachment Level (PAL) from baseline to 12 months
时间窗: baseline to 12 months
PAL is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the base of the pocket measured to the nearest millimeter using UNC - 15 probe
次要结局
- Gingival Index(baseline to 12 months)
- Plaque Index(baseline to 12 months)
研究者
Dr. Pallavi Meshram
Assistant Professor
Government Dental College and Hospital, India