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.

中文翻译：

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有和没有牙釉质基质衍生物治疗骨内缺损的无翻瓣方法：一项随机对照临床试验。


目的 比较无翻瓣手术单独或联合牙釉质基质衍生物 （EMD） 治疗深部骨内缺损的临床和影像学结果。材料和方法 将 46 例非手术治疗后重新评估的患者随机分配到试验组 （无瓣联合 EMD） 或对照组 （单独无瓣）。记录术前、术后 6 个月和 12 个月的临床测量结果，术前和 12 个月后进行放射学测量。结果 46 例患者完成了研究。在 12 个月时，两组的平均临床依恋水平 （CAL） 增加均有所改善，测试组 （3.9 ± 1.1 mm） 和对照组 （3.0 ± 1.2） 之间存在显着差异 （p = .017）。探诊袋深度 （PPD） 减少 （4.0 ± 0.7 vs. 3.3 ± 1.4 mm） 也接近统计学意义 （p = .051）。此外，在无瓣 + EMD 组中，更多部位实现了再生治疗的成功复合结果测量 （最终 PPD ≤ 4 mm，CAL 增益 ≥3 mm） （82.6% vs. 52.2%;p = .028）。在影像学结局方面，EMD 产生的缺损骨填充比单独的无瓣治疗更大 （3.0 ± 1.0 mm vs. 1.8 ± 1.5 mm;p < .001）。结论 在骨内缺损的无瓣手术中额外应用 EMD 略微改善了临床和影像学结局。CLINICALTRIALS 政府识别号：NCT05456555。