Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Clin Oral Investig. 2023 May;27(5):2385-2394. doi: 10.1007/s00784-023-04875-w. Epub 2023 Jan 31.
The aim of the present randomized clinical trial (RCT) with a parallel arm design was to evaluate the clinical and microbiological efficacy of repeated ICG-aPDT as an adjunct to full-mouth subgingival debridement in the treatment of periodontitis.
Twenty-four periodontitis patients were treated with full-mouth ultrasonic subgingival debridement (FMUD). Initial sites with probing depth (PD) > 4 mm were randomly assigned to receive the test (ICG-aPDT with an 810 nm diode laser) or the control treatment (off-mode aPDT) one and four weeks after FMUD. Clinical parameters were registered after 3 and 6 months. The presence of the main periodontal pathogens in subgingival samples was assessed with real-time PCR.
Both treatment modalities resulted in significant clinical improvements at 3 and 6 months. The only significant differences in favour of the test group were found at 6 months for a higher PD reduction in initial deep pockets (PD ≥ 6 mm) and a higher percentage of closed pockets (PD ≤ 4 mm/no bleeding on probing). Limited microbiological changes were observed in both groups after treatment with no inter-group difference, except for a more significant reduction in Aggregatibacter actinomycetemcomitans and Parvimonas micra levels in the test group at 3 months.
The combination of repeated ICG-aPDT and FMUD provided no benefits except for selective clinical and microbiological improvements compared to FMUD alone.
Based on the obtained results, only limited adjunctive effects could be found for the combined use of ICG-aPDT and FMUD. Further, well-designed RCT with larger sample sizes are required to confirm these findings.
ClinicalTrials.gov NCT04671394.
本平行臂设计的随机临床试验(RCT)的目的是评估重复使用 ICG-aPDT 作为全口龈下刮治辅助治疗牙周炎的临床和微生物疗效。
24 名牙周炎患者接受全口超声龈下刮治(FMUD)。初始探诊深度(PD)>4mm 的部位随机分配接受试验(810nm 二极管激光的 ICG-aPDT)或对照治疗(关闭模式 aPDT),分别在 FMUD 后 1 周和 4 周。在 3 个月和 6 个月时记录临床参数。使用实时 PCR 评估龈下样本中主要牙周病原体的存在。
两种治疗方法在 3 个月和 6 个月时均显著改善临床状况。仅在 6 个月时发现试验组有更高的初始深袋(PD≥6mm)PD 降低和更高比例的封闭袋(PD≤4mm/无探诊出血)的显著差异。两组治疗后均观察到有限的微生物学变化,两组间无差异,除了试验组在 3 个月时 Aggregatibacter actinomycetemcomitans 和 Parvimonas micra 水平的降低更显著。
与单独使用 FMUD 相比,重复使用 ICG-aPDT 和 FMUD 除了选择性的临床和微生物改善外,没有提供额外的益处。
根据获得的结果,仅发现 ICG-aPDT 与 FMUD 联合使用的辅助作用有限。需要进一步进行设计良好、样本量更大的 RCT 来证实这些发现。
ClinicalTrials.gov NCT04671394。