Department of Orthodontics and Orofacial Orthopedics, Universitätsklinikum Erlangen and Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Glückstr. 11, 91054, Erlangen, Germany.
Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitätsklinikum Erlangen and Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Wasserturmstraße 3/5, 91054, Erlangen, Germany.
BMC Oral Health. 2022 Apr 27;22(1):148. doi: 10.1186/s12903-022-02180-8.
Orthodontic treatment with fixed appliances is often necessary to correct malocclusions in adolescence or adulthood. However, oral hygiene is complicated by appliances, and prior studies indicate that they may trigger oral inflammation and dysbiosis of the oral microbiota, especially during the first 3 months after insertion, and, thus, may present a risk for inflammatory oral diseases. In recent periodontal therapeutic studies, probiotics have been applied to improve clinical parameters and reduce local inflammation. However, limited knowledge exists concerning the effects of probiotics in orthodontics. Therefore, the aim of our study is to evaluate the impact of probiotics during orthodontic treatment.
This study is a monocentric, randomized, double blind, controlled clinical study to investigate the effectiveness of daily adjuvant use of Limosilactobacillus reuteri (Prodentis®-lozenges, DSM 17938, ATCC PTA 5289) versus control lozenges during the first three months of orthodontic treatment with fixed appliances. Following power analysis, a total of 34 adolescent patients (age 12-17) and 34 adult patients (18 years and older) undergoing orthodontic treatment at the University Hospital Erlangen will be assigned into 2 parallel groups using a randomization plan for each age group. The primary outcome measure is the change of the gingival index after 4 weeks. Secondary outcomes include the probing pocket depth, the modified plaque index, the composition of the oral microbiota, the local cytokine expression and-only for adults-serum cytokine levels and the frequencies of cells of the innate and adaptive immune system in peripheral blood.
Preventive strategies in everyday orthodontic practice include oral hygiene instructions and regular dental cleaning. Innovative methods, like adjuvant use of oral probiotics, are missing. The aim of this study is to analyse, whether probiotics can improve clinical parameters, reduce inflammation and prevent dysbiosis of the oral microbiota during orthodontic treatment. If successful, this study will provide the basis for a new strategy of prophylaxis of oral dysbiosis-related diseases during treatment with fixed appliances.
This trial is registered at ClinicalTrials.gov in two parts under the number NCT04598633 (Adolescents, registration date 10/22/2020), and NCT04606186 (Adults, registration date 10/28/2020).
正畸治疗通常需要使用固定矫正器来矫正青少年或成年人的错颌畸形。然而，矫正器会使口腔卫生变得复杂，先前的研究表明，它们可能会引发口腔炎症和口腔微生物群落的失调，尤其是在矫正器插入后的头 3 个月，因此，可能会引发炎症性口腔疾病。在最近的牙周治疗研究中，益生菌已被应用于改善临床参数和减轻局部炎症。然而，关于正畸中益生菌的作用，目前知识有限。因此，我们的研究目的是评估正畸治疗中益生菌的影响。
这是一项单中心、随机、双盲、对照的临床研究，旨在调查在固定矫正器正畸治疗的头 3 个月中，每天辅助使用罗特乳杆菌（Prodentis®-锭剂，DSM 17938，ATCC PTA 5289）与对照锭剂的效果。根据功效分析，将总共 34 名青少年患者（12-17 岁）和 34 名成年患者（18 岁及以上）在埃尔兰根大学医院接受正畸治疗，将根据每个年龄组的随机分组计划分为 2 个平行组。主要观察指标是 4 周后牙龈指数的变化。次要观察指标包括探诊袋深度、改良菌斑指数、口腔微生物群落组成、局部细胞因子表达（仅针对成年人）和外周血固有和适应性免疫系统细胞的频率。
日常正畸实践中的预防策略包括口腔卫生指导和定期洁牙。缺少创新方法，如辅助使用口腔益生菌。本研究的目的是分析益生菌是否可以改善临床参数、减轻炎症并防止正畸治疗过程中口腔微生物群落失调。如果成功，这项研究将为固定矫正器治疗期间预防与口腔失调相关疾病提供新的策略基础。
该试验在 ClinicalTrials.gov 上分为两部分进行注册，编号为 NCT04598633（青少年，注册日期 2020 年 10 月 22 日）和 NCT04606186（成年人，注册日期 2020 年 10 月 28 日）。
