Treatment of Periodontal Intrabony Defects With Dense Leukocyte and Platelet-Rich Fibrin (L-PRF) Membrane Alone or in Combination With Collagen Membranes (Randomized Clinical and Biochemical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- CEJ to alveolar crest
研究概览
简要总结
For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes.
For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.
详细描述
- Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries.
- Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs.
- Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed.
- for OFD group; following debridement and saline irrigation, wound closure proceeds.
- for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure.
- for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure.
- from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus
- At 6 months postoperative: the same baseline clinical measurements are obtained.
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
- The clinical data (Gingival index, Plaque index, PPD, CAL) were collected by a blinded single operator at the university outpatient clinic.
- The biochemical analysis: The biochemist received the filter papers with a label for group letter and patient number. She was didn't know which intervention was carried out for any of the samples.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
- •2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
排除标准
- •Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
- •Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
- •Vulnerable groups
- •Interdental craters and 1 wall osseous defects
- •Active periapical pathosis
结局指标
主要结局
CEJ to alveolar crest
时间窗: 6 months
measures the amount of crystal bone changes
Gingival index
时间窗: 6 months
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Plaque index
时间窗: 6 months
measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces
Probing depth
时间窗: 6 months
measures the reduction in pocket depth
CEJ to base of defect
时间窗: 6 months
measures the changes in bone defect depth
Clinical attachment level
时间窗: 6 months
measures the changes in amount of periodontal attachment
次要结局
- PDGF(31 days)
- VEGF(31 days)
研究者
Ramy Mubarak Hussein
Principal investigator
Future University in Egypt