Multiband-/-Bracket Induced Qualitative and Quantitative Changes in the Oral Microbiome and Its Influence by Preventive Intervention Using Dietary Supplements
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- To count the number of bacterial colonization in saliva using next-generation-sequencing of the bacterial 16S rRNA gene.
研究概览
简要总结
The oral cavity's microbiome is a diverse community, hosting over 700 bacterial species. Due to its varied niches, the oral cavity constitutes a highly complex environment where different microbes preferentially colonize distinct habitats.
The aim of the study was to investigate the alteration of the oral microbiome during therapy with fixed orthodontic appliances using dietary supplements.
详细描述
In the randomized clinical trial, the effect of dietary supplements (vegetable juice) was investigated in patients treated with fixed orthodontic appliances. Saliva, tongue and subgingival samples were taken from each participant at three different time points: TO (before insertion of fixed orthodontic therapy), T1 14 days after daily administration of lettuce juice; T2 up to 6 months after washout. Orthodontic patients without dietary intervention served as controls. In addition, clinical indices were examined. Samples were analyzed by Illumina 16S rRNA sequencing and taxonomically assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age 12 to 99 years
- •Good general condition, healthy
- •Inflammation-free marginal periodontium
- •Metal brackets in the upper and lower jaw
排除标准
- •History of allergies
- •Self reported as being immunocompromised
- •Self-reported as pregnant or nursing
- •Self-reported serious medical conditions
- •Antibiotic or anti-inflammatory medication within 6 months before screening visit
结局指标
主要结局
To count the number of bacterial colonization in saliva using next-generation-sequencing of the bacterial 16S rRNA gene.
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To determine abundance up to genus level of bacteria in saliva in the intervention group (juice group) compared to control group using next-generation-sequencing.
Investigation of gingival indices using Periodontal Screening Index (PSI).
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To evaluate the effect of vegetable juice on the periodontal tissues in orthodontic patients in the upper and lower jaw (Score 0-4). 0: Healthy; 1: Bleeding on probing 2: Calculus 3: Dental pocket \> 3.5 mm 4: Dental pocket \> 5.5 mm
Investigation of gingival indices using Plaque Index (PI)
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To evaluate the plaque-reducing effect of vegetable juice in orthodontic patients in the upper and lower jaw. This index ascertains the thickness of plaque along the gingival margin (Sore 0-3); 0: No plaque 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Investigation of gingival indices using Sulcus Bleeding Index.
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To evaluate the inflammation-reducing effect of vegetable juice in orthodontic patients in the upper and lower jaw by counting bleeding on probing from tooth 17 to tooth 47 (Bleeding: yes, No bleeding: no)
To count the number of bacterial colonization on tongue using next-generation-sequencing of the bacterial 16S rRNA gene.
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To determine abundance up to genus level of bacteria in tongue samples in the intervention group (juice group) compared to control group using next-generation-sequencing.
To count the number of bacterial colonization in plaque using next-generation-sequencing of the bacterial 16S rRNA gene.
时间窗: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
To determine abundance up to genus level of bacteria in plaque samples in the intervention group (juice group) compared to control group using next-generation-sequencing.
次要结局
未报告次要终点
研究者
Dr. Elisabeth Reichardt
Principal Investigator
University Center of Dental Medicine Switzerland