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改良微创手术技术联合克林霉素增强或未增强的富血小板纤维蛋白用于牙周再生:一项随机临床试验

Modified minimally invasive surgical technique with clindamycin-augmented or non-augmented platelet-rich fibrin in periodontal regeneration: A randomized clinical trial.

作者信息

Yusri Sarah, Elbattawy Weam, Zaaya Salma, Mokhtar Maha, Ramzy Asmaa, Fawzy El-Sayed Karim M

机构信息

Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Proteomics and Metabolomics Research Program, Basic Research Department, Children's Cancer Hospital, Cairo, Egypt.

出版信息

J Periodontal Res. 2024 Sep 3. doi: 10.1111/jre.13344.

Abstract

AIM

Injectable platelet-rich fibrin (I-PRF), a second-generation platelet concentrate, is widely used to enhance soft and hard tissue healing alone or in combination with biomaterials, relying on its harboring of various pivotal growth/differentiation factors. This randomized trial assessed the effect of clindamycin (CLN) augmented injectable platelet-rich fibrin (I-PRF) with modified minimally invasive surgical technique (M-MIST) versus I-PRF alone with M-MIST on the clinical and radiographic parameters in the management of periodontal intra-bony defects in patients with stage-III grade B periodontitis.

METHODS

This is a 9-month parallel-grouped, two arm, double-blinded, randomized controlled trial (RCT) that included 28 patients (n = 28) with stage-III grade B periodontitis, who were allocated randomly to test- (CLN/I-PRF + M-MIST, 50 μL of CLN per 1 mL of I-PRF; n = 14) or control-group (I-PRF + M-MIST; n = 14). Clinical attachment level (CAL; primary outcome), probing depth (PD), gingival margin level (GML), plaque index (PI), and gingival index (GI) were recorded at baseline, 3, 6, and 9 months, whereas radiographic parameters radiographic linear defect depth (RLDD), and radiographic defect area (RDA) were recorded at baseline, 6, and 9 months. The CLN release kinetics from the I-PRF were further characterized.

RESULTS

Compared to baseline, both groups independently demonstrated significant improvements in CAL, PD, GML, GI, PI, RLDD and BDA at 3, 6 and 9 months (p < .05). A significant reduction in CAL measurements was noticeable in the CLN/I-PRF + M-MIST and I-PRF + M-MIST group independently over time (p < .05). CLN/I-PRF + M-MIST showed significantly lower CAL than PRF + M-MIST group at baseline, after three as well as 9 months (p < .05). Intergroup comparisons at 9 months demonstrated that CAL-gain was non-significant between groups (p > .05), GI significantly lower in CLN/I-PRF + M-MIST, whereas PD-reduction significantly higher I-PRF + M-MIST group (p < .05). CLN was steadily released for the I-PRF for up to 48 h, with a peak concentration at 24 h, which then gradually declined till the seventh day.

CONCLUSIONS

I-PRF with M-MIST provided significant clinical and radiographic improvement up to 9 months postoperatively in stage-III grade B periodontitis. CLN, at the applied concentration and release duration, does not appear to further positively impact these observed I-PRF effects.

摘要

目的

可注射富血小板纤维蛋白(I-PRF)作为第二代血小板浓缩物,因其含有多种关键生长/分化因子,被广泛用于单独或与生物材料联合促进软硬组织愈合。本随机试验评估了克林霉素(CLN)增强的可注射富血小板纤维蛋白(I-PRF)联合改良微创手术技术(M-MIST)与单独使用I-PRF联合M-MIST对III B期牙周炎患者牙周骨内缺损临床和影像学参数的影响。

方法

这是一项为期9个月的平行分组、双臂、双盲随机对照试验(RCT),纳入28例III B期牙周炎患者(n = 28),随机分为试验组(CLN/I-PRF + M-MIST,每1 mL I-PRF中含50 μL CLN;n = 14)或对照组(I-PRF + M-MIST;n = 14)。在基线、3个月、6个月和9个月时记录临床附着水平(CAL;主要结局指标)、探诊深度(PD)、牙龈边缘水平(GML)、菌斑指数(PI)和牙龈指数(GI),而在基线、6个月和9个月时记录影像学参数,即影像学线性缺损深度(RLDD)和影像学缺损面积(RDA)。进一步对I-PRF中CLN的释放动力学进行了表征。

结果

与基线相比,两组在3个月、6个月和9个月时,CAL、PD、GML、GI、PI、RLDD和BDA均有显著改善(p < 0.05)。随着时间的推移,CLN/I-PRF + M-MIST组和I-PRF + M-MIST组的CAL测量值均显著降低(p < 0.05)。在基线、3个月和9个月时,CLN/I-PRF + M-MIST组的CAL均显著低于PRF + M-MIST组(p < 0.05)。9个月时的组间比较显示,两组间CAL增益无显著差异(p > 0.05),CLN/I-PRF + M-MIST组的GI显著更低,而I-PRF + M-MIST组的PD降低显著更高(p < 0.05)。CLN在I-PRF中持续释放长达48小时,在24小时达到峰值浓度,然后逐渐下降直至第7天。

结论

I-PRF联合M-MIST在III B期牙周炎患者术后9个月内可提供显著的临床和影像学改善。在所应用的浓度和释放持续时间下CLN似乎并未对这些观察到的I-PRF效果产生进一步的积极影响。

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