The Effect of Probiotic Lactobacillus Reuteri Prodentis Consumption on Gingival Crevicular Fluid Inflammatory Response and Metagenomic Profiles of Oral Microbiome in Orthodontic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Metagenomic microbiome profile comparison between Pre- and Post-treatment described using Alpha Diversity analysis.
研究概览
简要总结
In this study, researchers will test the effectiveness of probiotic consumption against oral pathogenic bacteria and reduce the occurrence of gingival inflammation in subjects using orthodontic fixed appliances (braces).
Lactobacillus reuteri is one of the probiotic bacteria that has been identified for its health benefits. L. reuteri produces antimicrobial substances, reuterin and reutericyclin which are active against wide range of pathogenic organisms. Previously, investigator performed a pilot study on the beneficial health effect of probiotic L. reuteri containing lozenges on a few orthodontic patients and it was proven that taking this probiotic for two weeks could significantly reduce the number of pathogenic bacteria in the patients' saliva. In vitro study showed that L. reuteri has the ability to modulate the inflammatory response such as TNF alpha and interleukins. However, The ability of L. reuteri in modulating the inflammatory response viz. Interleukin 1-beta, Interleukin 6, interleukin 8, interleukin 10, TNF alpha, MMP-9 and RANKL and effect on oral metagenomic microbiome profile in patients undergoing orthodontic treatment has not been previously investigated.
Objective:
- To evaluate the effect of consumption of L. reuteri Prodentis probiotic lozenges on the inflammatory response (inflammation) of gingival fluid.
- To evaluate the effect of consumption of the probiotic lozenges of L. reuteri Prodentis against oral pathogens in dental plaque and saliva.
Research Benefits:
This study was conducted to observe the effectiveness of L. reuteri (ProDentis) probiotic against oral pathogenic bacteria on patients using orthodontic fixed appliance, to reduce gum inflammation and improve oral health.
详细描述
Rationale and background of the study
Aesthetics is a primary consideration for patients seeking orthodontic treatment. However, apart from esthetic aspects, the malalignment of teeth may also cause health concerns affecting oral function such as mastication, speech, and psychosocial problems due to impaired dentofacial aesthetics. Hence, the subjects undergoing fixed orthodontic treatment may come across several oral health related issues. The fixed orthodontic treatment is known to place the subject at risk of accumulation of heavy dental plaque which alters the symbiotic ecosystem of oral microbiome. This leads to dysbiotic oral micrbiome which harbore more pathogenic species. It has been shown pathogenic S. mutans, P. gingivalis, A. actinomycetemcomitans and C. albicans are present in orthodontic patients who do not pay enough attention to oral hygiene procedures.
S. mutans is a facultative anaerobic Gram-positive oral bacteria that has an important role in developing dental caries. P. gingivalis and A. actinomycetemcomitans are an anaerobic Gram-negative oral bacteria associated with periodontitis. Data from The National Health and Nutrition Examination Survey (NHANES III) suggest 14% orthodontic patients in the US over 20 years of age have moderate to severe periodontitis. Moreover, presence and pathogenic potential of C. albicans in periodontal pocket of these patients has been shown. C. albicans is a robust biofilm-forming organism, presenting therapeutic complication.
L. reuteri is a commensal oral probiotic bacterium, that is known to a produce antibacterial compound, reuterin. The structure of this broad-spectrum antimicrobial is related to hydroxypropionaldehyde, which formed during fermentation with glycerol. Previous studies have shown beneficial effect of reuterin against pathogenic oral bacteria. Moreover, it is safe to be used as chewing gums or yoghurts. Furthermore, previous study found that L. reuteri-containing gum was effective in reducing plaque accumulation and gingivitis in patient with moderate to severe gingivitis. Therefore, L. reuteri-containing chewing gum has considerable evidence to be used for the improvement of oral health.
Preliminary data: As a pilot study, investigators collected saliva samples from eight orthodontic patients (mean age 21 years) before and two weeks after daily probiotic consumption. A duplicate sample was collected from each subject. The results showed significant reductions in S. mutans serotype c, S. mutans serotype d, P. gingivalis, and A. actinomycetemcomitans after probiotic consumption (p<0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open label trial of BioGaia's Probiotic lozenges
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 28 years old (M/F)
- •Using orthodontic fixed appliance for at least 1 year
- •Do not consume probiotics and antibiotics (at least 3 months before)
- •No history of systemic disease
排除标准
- •Subjects with systemic diseases
- •Allergic to probiotics
研究组 & 干预措施
L.reuterii probiotic lozenges from BioGaia
Subjects were willing to provide 2 samples of saliva, dental plaque and gingival fluid (gum fluid), on the first day (before consuming lozenges) and on the 14th day after the subject consumed lozenges containing L. reuteri probiotic. Probiotics are taken once a day for two weeks after breakfast and brushing their teeth.
干预措施: BioGaia Probiotic Lozenges (Dietary Supplement)
结局指标
主要结局
Metagenomic microbiome profile comparison between Pre- and Post-treatment described using Alpha Diversity analysis.
时间窗: 8 weeks
Using next-generation sequencing to acquire both bacterial and fungal metagenomic profile from plaque, gingival crevicular fluid, and saliva samples, whilst comparing both profile between pre-treatment and post-treatment. The data will be analysed and presented after observed operational taxonomic units (OTU), Shannon's richness, Chao's richness, and Simpson's evenness analysis has been done.
Bacterial gene expression profile from dental plaque comparison between Pre- and Post-treatment described using relative quantification of fold gene expression (2-∆∆Ct).
时间窗: 16 weeks
Using RT-PCR to acquire the gene expression of bacterial dental plaque that are acquired from both pre-treatment and post-treatment samples, therefore comparing bacterial dental plaque's gene expression between pre-treatment and post-treatment.
Proteomic profile assessed from gingival crevicular fluid and comparing its results between Pre- and Post-treatment as assessed using enzyme-linked immunosorbant assay.
时间窗: 12 weeks
Using enzyme-linked immunosorbant assay to assess inflammatory responses and comparing it between pre-treatment samples and post-treatment samples. Standard curves for each marker will also be conducted. Final protein concentrations of each marker will be generated after the sample's absorbance value detected is converted using the standard curve of each marker.
OHI status and Plaque index as assessed by the dental general practitioners.
时间窗: 2 weeks
Assessment done by dentists to analyze oral health comparisons between pre-treatment and post-treatment
次要结局
未报告次要终点
研究者
Armelia Sari Widyarman
Lecturer, Head of Microbiology Department, Head of MiCORE Laboratory
Trisakti University