Rosa Ellen Perim, Murakami-Malaquias-Silva Felipe, Schalch Tânia Oppido, Teixeira Daniela Bezerra, Horliana Ricardo Fidos, Tortamano Andre, Tortamano Isabel Peixoto, Buscariolo Inês Aparecida, Longo Priscila Larcher, Negreiros Renata Matalon, Bussadori Sandra Kalil, Motta Lara Jansiski, Horliana Anna Carolina Ratto Tempestini
Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil.
Academic specialization student in Temporomandibular Disorder and Orofacial pain.
Medicine (Baltimore). 2020 Apr;99(14):e19429. doi: 10.1097/MD.0000000000019429.
It is known that the presence of orthodontic brackets predisposes for a change in the biofilm, facilitating the development of gingivits. The sites are difficult to access with a toothbrush and periodontal curette, worsening inflammation, in addition, a gingival hyperplasia is associated with poor hygiene. The objective of this study is to evaluate the impact of photodinamyc therapy (PDT) as an adjuvant treatment, considering clinical immunoregulatory and microbiological parameters. This randomized, controlled, double-blind clinical study will include 34 patients, both genders, having used fixed appliance for more than 12 months, with gingivitis. Participants will be divided into two groups: G1 (n = 17)- Scaling and Root Planing + PDT placebo and G2 (n = 17)- Scaling and Root Planing + PDT. In G2 the following dosimetric parameters will be used: methylene blue 0.005%, λ= 660 nanometers (nm), 9 Joules (J) per site, irradiance= 3.5Watts (W)/ centimeters (cm), radiant exposure= 318J/cm. All participants will receive oral hygiene guidance prior the curetes scaling. The clinical periodontal data to be analyzed are plaque index, gingival index and probing depth. Crevicular fluid, from 4 pre-determined sites and saliva, will be collected and analysed for IL-6, IL-1β, IL-8, TNF-α and IL-10 cytokines using ELISA (Enzyme immunoabsorption assay) method. Total Bacteria count will also be performed, by qPCR and Universal16SrRNA gene. All analysis will be realized using in the baseline (T0), 7 (T1) and 21 (T2) days after treatment. Oral health-related quality of life will be assessed using the OHIP-14 questionnaire at times T0 and T2. If sample distribution is normal, the Student T-test will be applied if it is not normal, the Mann-Whitney test will be used. The data will be presented in terms of ± PD and The significance level will be set at p < 0.05. Our results may improve quality of life and add data to establish a therapeutic alternative for gingivitis during the orthodontic treatment. Registration: clinicaltrials.gov NCT04037709. https://clinicaltrials.gov/ct2/show/NCT04037709 - Registered in July 2019.
众所周知，正畸托槽的存在会使生物膜发生改变，从而促进牙龈炎的发展。这些部位用牙刷和牙周刮匙难以触及，会加重炎症，此外，牙龈增生与口腔卫生不良有关。本研究的目的是评估光动力疗法（PDT）作为辅助治疗的效果，同时考虑临床免疫调节和微生物学参数。这项随机、对照、双盲临床研究将纳入34名使用固定矫治器超过12个月且患有牙龈炎的患者，男女不限。参与者将被分为两组：G1（n = 17）——龈下刮治术+PDT安慰剂组和G2（n = 17）——龈下刮治术+PDT组。在G2组中，将使用以下剂量参数：0.005%的亚甲蓝，λ = 660纳米（nm），每个部位9焦耳（J），辐照度 = 3.5瓦特（W）/厘米（cm），辐射暴露量 = 318J/cm。所有参与者在刮治术前均会接受口腔卫生指导。待分析的临床牙周数据包括菌斑指数、牙龈指数和探诊深度。将从4个预先确定的部位收集龈沟液和唾液，并用酶联免疫吸附测定（ELISA）法分析其中的白细胞介素-6（IL-6）、白细胞介素-1β（IL-1β）、白细胞介素-8（IL-8）、肿瘤坏死因子-α（TNF-α）和白细胞介素-10（IL-10）细胞因子。还将通过定量聚合酶链反应（qPCR）和通用16S核糖体RNA基因进行细菌总数检测。所有分析将在治疗后的基线（T0）、7天（T1）和21天（T2）进行。将在T0和T2时间点使用OHIP-14问卷评估口腔健康相关生活质量。如果样本分布呈正态，则应用学生t检验；如果样本分布不正常，则使用曼-惠特尼检验。数据将以±PD表示，显著性水平设定为p < 0.05。我们的研究结果可能会改善生活质量，并为正畸治疗期间的牙龈炎建立一种治疗选择提供更多数据。注册信息：clinicaltrials.gov NCT04037709。https://clinicaltrials.gov/ct2/show/NCT04037709 - 于2019年7月注册。
