Nutrition, Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVegetable juice
Vegetable juice (Fa. Fitrabbit, Voglsam)
Sponsors
University Center of Dental Medicine Switzerland
University of Wuerzburg
Helmholtz Centre for Infection Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient age 12 to 99 years * Good general condition, healthy * Inflammation-free marginal periodontium * Metal brackets in the upper and lower jaw
Exclusion criteria
* 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 * Smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of gingival indices using Plaque Index (PI) | 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 Periodontal Screening Index (PSI). | 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 Sulcus Bleeding Index. | 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. | 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. | 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. |
| To count the number of bacterial colonization in saliva using next-generation-sequencing of the bacterial 16S rRNA gene. | 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. |
Countries
Germany, Switzerland
Outcome results
None listed