Emanuel Noam, Machtei Eli E, Reichart Malka, Shapira Lior
Quintessence Int. 2020;51(7):546-553. doi: 10.3290/j.qi.a44629.
In the present pilot, multicenter, randomized, single-blinded, controlled study, surgical treatment with or without the administration of D-PLEX500 (a biodegradable prolonged release local doxycycline formulated with β-tricalcium phosphate bone graft) was accessed for the treatment of peri-implantitis.
Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation were randomly assigned, to adjunct D-PLEX500 placement group or to control group. Clinical and radiographic parameters were measured at 6 and 12 months.
Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants) were randomized to the test group and 13 (14 implants) to the control group. There was no difference in plaque scores between the groups. There was no difference in the changes of mean periodontal probing depth between the test and control groups between baseline and the 6-month follow-up, whereas statistically significant difference was observed after 12 months' follow-up when analyzed for all sites averaged. There was a statistically significant difference in the changes of clinical attachment levels and radiographic bone levels between the groups between baseline and 12 months. These improvements were demonstrated when analyzed at both implant and subject levels. Only D-PLEX500 treatment led to improved bone levels at both time points. The improvement in bone levels was significant in the D-PLEX500 treatment group already after 6 months, and further improved over the 12-month follow-up. Implants were lost only in the control group (14%).
D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions. The antibacterial component of the bone graft material might create favorable conditions that enable implant surface decontamination and soft and hard tissue healing over a prolonged period.
在本试点多中心随机单盲对照研究中，评估采用或不采用D-PLEX500（一种与β-磷酸三钙骨移植材料制成的可生物降解长效局部强力霉素）进行手术治疗对种植体周围炎的疗效。
翻瓣术后接受骨内种植体周围炎缺损手术治疗的受试者被随机分配至D-PLEX500辅助植入组或对照组。在6个月和12个月时测量临床和影像学参数。
共纳入27名受试者（平均年龄：64.81±7.61岁）；14例患者（18颗种植体）被随机分配至试验组，13例患者（14颗种植体）被分配至对照组。两组之间的菌斑评分无差异。试验组和对照组在基线至6个月随访期间平均牙周探诊深度的变化无差异，而在对所有部位进行平均分析时，12个月随访后观察到统计学显著差异。两组在基线至12个月期间临床附着水平和影像学骨水平的变化存在统计学显著差异。在种植体和受试者水平进行分析时均显示出这些改善。仅D-PLEX500治疗在两个时间点均导致骨水平改善。D-PLEX500治疗组在6个月后骨水平即有显著改善，并在12个月随访期间进一步改善。仅对照组有种植体丢失（14%）。
与骨填充材料制成的D-PLEX500缓释局部抗生素在促进种植体周围炎病变愈合方面显示出有前景的结果。骨移植材料的抗菌成分可能创造有利条件，使种植体表面在较长时间内得以去污，并促进软硬组织愈合。
