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无瓣切口联合和不联合釉基质衍生物治疗骨内缺损的随机对照临床试验。

The flapless approach with and without enamel matrix derivatives for the treatment of intrabony defects: A randomized controlled clinical trial.

机构信息

Department of Surgical Sciences, C.I.R. Dental School, University of Turin, Turin, Italy.

出版信息

J Clin Periodontol. 2024 Sep;51(9):1112-1121. doi: 10.1111/jcpe.14028. Epub 2024 Jun 10.

DOI:10.1111/jcpe.14028
PMID:38859627
Abstract

AIM

To compare the clinical and radiographic outcomes of flapless procedure alone or in combination with enamel matrix derivatives (EMD) in the treatment of deep intrabony defects.

MATERIALS AND METHODS

Forty-six patients re-evaluated after non-surgical therapy were randomly assigned to the test (flapless with EMD) or control group (flapless alone). Clinical measurements were recorded pre-surgery and at 6 and 12 months after surgery, and radiographic measurements were taken pre-surgery and after 12 months.

RESULTS

Forty-six patients completed the study. Improvements were observed in both groups at 12 months for mean clinical attachment level (CAL) gain, with significant differences between test (3.9 ± 1.1 mm) and control groups (3.0 ± 1.2) (p = .017). Probing pocket depth (PPD) reduction (4.0 ± 0.7 vs. 3.3 ± 1.4 mm) was also near to statistical significance (p = .051). Also, more sites achieved successful composite outcome measure (final PPD ≤ 4 mm and CAL gain ≥3 mm) for the regenerative treatment in the flapless + EMD group (82.6% vs. 52.2%; p = .028). In terms of radiographic outcomes, EMD yielded a greater defect bone fill than flapless treatment alone (3.0 ± 1.0 mm vs. 1.8 ± 1.5 mm; p < .001).

CONCLUSIONS

The additional application of EMD during the flapless procedure for intrabony defects slightly improved clinical and radiographic outcomes.

CLINICALTRIALS

gov identification number: NCT05456555.

摘要

目的

比较无瓣手术单独或联合使用釉基质衍生物(EMD)治疗深骨内缺损的临床和影像学效果。

材料和方法

对非手术治疗后重新评估的 46 例患者进行随机分组,分别进入试验组(无瓣+EMD)和对照组(无瓣)。临床测量在术前和术后 6 个月和 12 个月进行记录,影像学测量在术前和术后 12 个月进行。

结果

46 例患者完成了研究。两组在术后 12 个月时的平均临床附着水平(CAL)均有改善,试验组(3.9±1.1mm)和对照组(3.0±1.2mm)之间存在显著差异(p=0.017)。探诊袋深度(PPD)的减少(4.0±0.7mm 与 3.3±1.4mm)也接近统计学意义(p=0.051)。此外,在无瓣+EMD 组,更多的部位达到了再生治疗的综合结果测量(最终 PPD≤4mm 和 CAL 增加≥3mm)(82.6%与 52.2%;p=0.028)。在影像学结果方面,EMD 比无瓣治疗单独使用时产生了更大的骨缺损填充(3.0±1.0mm 与 1.8±1.5mm;p<0.001)。

结论

在无瓣手术中额外应用 EMD 可略微改善临床和影像学效果。

临床试验

gov 注册号:NCT05456555。

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