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富血小板纤维蛋白和骨移植材料(β-磷酸三钙+羟基磷灰石)治疗牙周炎患者骨内缺损的临床和影像学评价:一项随机对照试验。

Clinical and radiographic evaluation of platelet-rich fibrin and bone graft material (β-tricalcium phosphate + hydroxyapatite) in the treatment of intrabony defects of periodontitis patients: a randomized controlled trial.

出版信息

Quintessence Int. 2023 Jun 26;54(6):472-483. doi: 10.3290/j.qi.b3920301.

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.

METHOD AND MATERIALS

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.

CONCLUSION

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

本研究旨在评估一种骨移植材料(β-磷酸三钙+羟基磷灰石)单独使用和与富含血小板纤维蛋白结合使用在牙周炎患者的骨内缺损中的临床和放射学效果。

方法和材料

这是一项为期 6 个月的随机对照临床试验,在 42 个骨内牙周缺损(平均年龄 40 岁)中进行。在第一阶段牙周治疗后,有≥3mm的骨内缺损和≥5mm的相关探诊深度的患者,采用翻开瓣清创术加骨移植(β-磷酸三钙+羟基磷灰石;对照组)或翻开瓣清创术加富含血小板纤维蛋白膜的骨移植(实验组)治疗。使用定制的个体化丙烯酸支架,带有凹槽,以确保临床和放射学参数的可重复和可重复测量,包括探诊袋深度(PPD)、相对临床附着水平(RCAL)、牙龈边缘水平(GML)、垂直骨缺损填充(VHD)和骨内缺损面积(AOD)在口腔根尖射线照片上。临床附着水平(CAL)的增加被认为是主要结果,PPD 减少和放射学骨填充是次要结果。

结果

对照组术前菌斑指数、RCAL、GML、PPD、VHD 和 AOD 分别为 1.06±0.08、11.57±2.29mm、5.24±1.89mm、6.29±1.52mm、14.36±2.65mm和 7.79±4.39mm2。6 个月后,这些分别为 1.08±0.14、9.34±2.54mm、5.81±2.20mm、3.52±0.93mm、12.64±2.34mm和 5.34±3.2mm2。实验组术前 PI、RCAL、GML、PPD、VHD 和 AOD 分别为 1.14±0.05、12.19±2.86mm、4.38±1.63mm、7.81±2.6mm、13.46±3.42mm和 10.31±8.71mm2。6 个月后,这些分别为 1.09±0.12、8.62±2.62mm、4.90±1.79mm、3.71±1.68mm、10.10±2.07mm和 4.38±2.67mm2。经过 6 个月的评估,两组患者的 PPD(P<0.001)和 CAL(P<0.001)均显著减少,VHD 填充和 AOD 变化的放射学改善也显著。同样,实验组在相同的结果方面显示出比对照组更显著的变化(P<0.001)。

结论

考虑到研究的局限性,可以得出结论,对于使用骨移植材料(β-磷酸三钙+羟基磷灰石;BIOGRAFT,IFGL 生物陶瓷)或相同的骨移植材料加富含血小板纤维蛋白膜治疗骨内缺损,在临床(CAL 和 PPD)和放射学(VHD 和 AOD)参数方面均有统计学意义上的显著改善,后者具有高度显著的益处。然而,骨移植材料需要改进。

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