Evangelista Erika Elisabeth, França Cristiane Miranda, Veni Priscila, de Oliveira Silva Tamires, Gonçalves Rafael Moredo, de Carvalho Verônica Franco, Deana Alessandro Melo, Fernandes Kristianne P S, Mesquita-Ferrari Raquel A, Camacho Cleber P, Bussadori Sandra Kalil, Alvarenga Letícia Heineck, Prates Renato Araujo
Program in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil.
School of Medicine, Nove de Julho University UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil.
Trials. 2015 May 27;16:229. doi: 10.1186/s13063-015-0757-3.
The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic control and increases proteins found in the acute phase of inflammation, such as C-reactive protein. The gold standard for the treatment of periodontal disease is oral hygiene orientation, scaling and planing. Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an antimicrobial technique and has demonstrated promising results. The aim of the proposed study is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the metabolic control of individuals with type 2 diabetes and the reduction of acute-phase inflammatory markers.
METHODS/DESIGN: The patients will be randomized using a proper software program into two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by a specialist, followed by PT performed by two other healthcare professionals. At the end of each session, PDT (active or placebo) will be administered by a fourth healthcare professional. The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW; exposure time = 90 s per point (9 J/point); and energy density = 22 J/cm(2). The photosensitizer will be methylene blue (50 μg/mL). The patients will be re-evaluated 15, 30, 90 and 180 days after treatment. Serological examinations with complete blood count, fasting glucose, glycated hemoglobin and salivary examinations to screen for tumor necrosis factor alpha, interleukin 1, interleukin 6, ostelocalcin, and osteoprotegerin/RANKL will be performed at each evaluation. The data will be statistically evaluated using the most appropriate tests.
The results of this study will determine the efficacy of photodynamic therapy as an adjuvant to periodontal treatment in diabetic patients.
The protocol for this trial was registered with Clinical Trials registration number NCT01964833 on 14 October 2013.
糖尿病（DM）与牙周病之间的关系是双向的。糖尿病是牙周炎的一个易感和影响因素，反过来，牙周炎会恶化血糖控制，并增加炎症急性期发现的蛋白质，如C反应蛋白。牙周病治疗的金标准是口腔卫生指导、龈上洁治和龈下刮治。此外，在某些情况下可能会采用全身抗生素治疗。为尽量减少抗生素的处方，光动力疗法（PDT）已作为一种抗菌技术进行研究，并已显示出有前景的结果。本拟议研究的目的是确定光动力疗法作为牙周治疗（PT）的补充，是否有助于2型糖尿病患者的代谢控制以及降低急性期炎症标志物。
方法/设计：将使用适当的软件程序将患者随机分为两组：1）牙周治疗+安慰剂光动力疗法或2）牙周治疗+活性光动力疗法。所有患者首先由一名专家进行检查，然后由另外两名医护人员进行牙周治疗。在每次治疗结束时，由第四名医护人员进行光动力疗法（活性或安慰剂）。光动力疗法参数如下：二极管激光（660纳米）；输出功率 = 110毫瓦；曝光时间 = 每点90秒（9焦耳/点）；能量密度 = 22焦耳/平方厘米。光敏剂将为亚甲蓝（50微克/毫升）。治疗后15、30、90和180天对患者进行重新评估。每次评估时将进行全血细胞计数、空腹血糖、糖化血红蛋白的血清学检查以及唾液检查，以筛查肿瘤坏死因子α、白细胞介素1、白细胞介素6、骨钙素和骨保护素/核因子κB受体活化因子配体。将使用最合适的测试对数据进行统计学评估。
本研究结果将确定光动力疗法作为糖尿病患者牙周治疗辅助手段的疗效。
本试验方案于2013年10月14日在临床试验注册中心注册，注册号为NCT01964833。
