Abstract：
OBJECTIVE: The present study aimed to assess the clinical and radiographic effect of a bone graft material (β-tricalcium phosphate + hydroxyapatite) alone and in combination with platelet-rich fibrin in intrabony defects of periodontitis patients.
METHODS: This 6-month randomized controlled clinical trial was carried out in 42 intrabony periodontal defects (average age 40 years). Intrabony defects ≥ 3 mm along with associated probing depth of ≥ 5 mm following phase 1 periodontal therapy were treated either with open flap debridement with bone graft (β-tricalcium phosphate + hydroxyapatite; control group) or open flap debridement with bone graft plus platelet-rich fibrin membrane (test group). Individual customized acrylic stents with grooves were used to ensure reproducible and repeatable measurements of clinical and radiographic parameters, including probing pocket depth (PPD), relative clinical attachment level (RCAL), gingival marginal level (GML), vertical bone defect fill (VHD), and area of intrabony defects (AOD) on intraoral periapical radiographs. Clinical attachment level (CAL) gain was considered as primary outcome and PPD reduction and radiographic bone fill as secondary outcomes.
RESULTS: The preoperative Plaque Index, RCAL, GML, PPD, VHD, and AOD in the control group were 1.06 ± 0.08, 11.57 ± 2.29 mm, 5.24 ± 1.89 mm, 6.29 ± 1.52 mm, 14.36 ± 2.65 mm, and 7.79 ± 4.39 mm2, respectively. After 6 months these were 1.08 ± 0.14, 9.34 ± 2.54 mm, 5.81 ± 2.20 mm, 3.52 ± 0.93 mm, 12.64 ± 2.34 mm, and 5.34 ± 3.2 mm2, respectively. The preoperative PI, RCAL, GML, PPD, VHD, and AOD in the experimental group were 1.14 ± 0.05, 12.19 ± 2.86 mm, 4.38 ± 1.63 mm, 7.81 ± 2.6 mm, 13.46 ± 3.42 mm, and 10.31 ± 8.71 mm2, respectively. After 6 months these were 1.09 ± 0.12, 8.62 ± 2.62 mm, 4.90 ± 1.79 mm, 3.71 ± 1.68 mm, 10.10 ± 2.07 mm, and 4.38 ± 2.67 mm2, respectively. After 6 months of evaluation both the groups showed a significant reduction in PPD (P < .001) and a significant gain in CAL (P < .001), as well as significant improvement in radiographic VHD fill and AOD changes. Again, the test group showed significant changes (P < .001) over the control group considering the same outcomes.
CONCLUSIONS: With the study limitations in mind, it can be concluded that for the treatment of intrabony defects with the bone graft material (β-tricalcium phosphate + hydroxyapatite; Biograft, IFGL Bio Ceramics) or the same bone graft with platelet-rich fibrin membrane results in statistically significant improvement in clinical (CAL and PPD) and radiographic (VHD and AOD) parameters, the latter having highly significant benefits. However, the bone graft material requires improvement.
METHODS: This 6-month randomized controlled clinical trial was carried out in 42 intrabony periodontal defects (average age 40 years). Intrabony defects ≥ 3 mm along with associated probing depth of ≥ 5 mm following phase 1 periodontal therapy were treated either with open flap debridement with bone graft (β-tricalcium phosphate + hydroxyapatite; control group) or open flap debridement with bone graft plus platelet-rich fibrin membrane (test group). Individual customized acrylic stents with grooves were used to ensure reproducible and repeatable measurements of clinical and radiographic parameters, including probing pocket depth (PPD), relative clinical attachment level (RCAL), gingival marginal level (GML), vertical bone defect fill (VHD), and area of intrabony defects (AOD) on intraoral periapical radiographs. Clinical attachment level (CAL) gain was considered as primary outcome and PPD reduction and radiographic bone fill as secondary outcomes.
RESULTS: The preoperative Plaque Index, RCAL, GML, PPD, VHD, and AOD in the control group were 1.06 ± 0.08, 11.57 ± 2.29 mm, 5.24 ± 1.89 mm, 6.29 ± 1.52 mm, 14.36 ± 2.65 mm, and 7.79 ± 4.39 mm2, respectively. After 6 months these were 1.08 ± 0.14, 9.34 ± 2.54 mm, 5.81 ± 2.20 mm, 3.52 ± 0.93 mm, 12.64 ± 2.34 mm, and 5.34 ± 3.2 mm2, respectively. The preoperative PI, RCAL, GML, PPD, VHD, and AOD in the experimental group were 1.14 ± 0.05, 12.19 ± 2.86 mm, 4.38 ± 1.63 mm, 7.81 ± 2.6 mm, 13.46 ± 3.42 mm, and 10.31 ± 8.71 mm2, respectively. After 6 months these were 1.09 ± 0.12, 8.62 ± 2.62 mm, 4.90 ± 1.79 mm, 3.71 ± 1.68 mm, 10.10 ± 2.07 mm, and 4.38 ± 2.67 mm2, respectively. After 6 months of evaluation both the groups showed a significant reduction in PPD (P < .001) and a significant gain in CAL (P < .001), as well as significant improvement in radiographic VHD fill and AOD changes. Again, the test group showed significant changes (P < .001) over the control group considering the same outcomes.
CONCLUSIONS: With the study limitations in mind, it can be concluded that for the treatment of intrabony defects with the bone graft material (β-tricalcium phosphate + hydroxyapatite; Biograft, IFGL Bio Ceramics) or the same bone graft with platelet-rich fibrin membrane results in statistically significant improvement in clinical (CAL and PPD) and radiographic (VHD and AOD) parameters, the latter having highly significant benefits. However, the bone graft material requires improvement.
摘要：
目的：本研究旨在评估骨移植（BG）材料（β-磷酸三钙羟基磷灰石）单独以及与富血小板纤维蛋白（PRF）联合治疗牙周炎患者骨内缺损（IBD）的临床和影像学效果。
方法：这是一项为期6个月的随机对照临床试验，在42例牙周炎IBDs中进行（平均年龄40岁）。I期治疗后，IBD≥3mm以及相关的探查深度≥5mm，采用带骨移植物的开放皮瓣清创（OFD）治疗（β-磷酸三钙羟基磷灰石-即，对照组)或采用植骨加PRF膜的OFD(即，测试组)。单独定制的带凹槽的丙烯酸支架用于确保临床和影像学参数的可重复和可重复测量。包括探测袋深度(PPD)，相对附着损失(RAL)，牙龈边缘水平(GML)，口内根尖周X线片上的垂直骨缺损填充（VHD）和IBD面积（AOD）。PPD减少和CAL增加被认为是主要结果，影像学骨填充被认为是次要结果。[CTRI/2012/07/002793]结果：术前PI，RAL,GML。PPD,对照组VHD&AOD为1.06±0.08,11.57±2.29mm,5.24±1.89mm,6.29±1.52mm,14.36±2.65mm,&7.79±4.39mm2，而6个月后为1.08±0.14，9.34±2.54mm，5.81±2.20mm,3.52±0.93mm,12.64±2.34mm,分别为5.34±3.2mm2。术前PI,RAL,GML。PPD,实验组的VHD和AOD为1.14±0.05，12.19±2.86mm，4.38±1.63mm,7.81±2.6mm,13.46±3.42mm,&10.31±8.71mm2，而6个月后为1.09±0.12，8.62±2.62mm，4.90±1.79mm,3.71±1.68mm,10.10±2.07mm,4.38±2.67mm2。经过6个月的评估，两组均显示PPD显着降低（p<0.001）和CAL显着增加（p<0.001），射线照相VHD填充和AOD变化显着改善。再一次,考虑到相同的结果,实验组与对照组相比有显著变化(p<0.001).
结论：考虑到研究的局限性，我们的结论是，用骨移植物(β-磷酸三钙+羟基磷灰石)材料或其与PRF膜一起治疗骨内缺损导致临床(CAL和PPD)和放射照相(VHD和AOD)参数的统计学显著改善;后者具有非常显著的益处。本土骨移植材料需要改进。
方法：这是一项为期6个月的随机对照临床试验，在42例牙周炎IBDs中进行（平均年龄40岁）。
结论：考虑到研究的局限性，
