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Active, not recruitingNCT06411977Updated Jul 19, 2024

Effect of Dietary Supplements on the Oral Microbiome

An interventional study of Vegetable juice in Nutrition, Healthy, sponsored by University Center of Dental Medicine Switzerland. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 12 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by University Center of Dental Medicine Switzerland · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 years 9 months after the study started (first participant enrolled Jul 2020, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
12 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nutrition, Healthy
03

In context

Lead sponsor

This is the only study on the registry with University Center of Dental Medicine Switzerland as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (estimated)

Study arms

  • No intervention
    Control group

    Orthodontic patients with fixed appliances

  • Other
    Juice group

    Orthodontic patients with fixed appliances with daily administration of vegetable juice up to 14 days

    Dietary Supplement: Vegetable juice

Interventions

  • Dietary supplementVegetable juice

    Vegetable juice (Fa. Fitrabbit, Voglsam)

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What researchers measure

Primary outcomes

  1. Investigation of gingival indices using Plaque Index (PI)

    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.

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

  2. Investigation of gingival indices using Periodontal Screening Index (PSI).

    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

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

  3. Investigation of gingival indices using Sulcus Bleeding Index.

    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)

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

  4. To count the number of bacterial colonization on tongue using next-generation-sequencing of the bacterial 16S rRNA gene.

    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.

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

  5. To count the number of bacterial colonization in plaque using next-generation-sequencing of the bacterial 16S rRNA gene.

    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.

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

  6. To count the number of bacterial colonization in saliva using next-generation-sequencing of the bacterial 16S rRNA gene.

    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.

    Time frame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

07

Study locations

2 sites
  • University of Wuerzburg
    Würzburg, Germany
  • University Center for Dental Medicine
    Basel, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06411977
Lead sponsor
University Center of Dental Medicine Switzerland
Collaborators
University of Wuerzburg, Helmholtz Centre for Infection Research
Responsible party
Dr. Elisabeth Reichardt (Principal Investigator, University Center of Dental Medicine Switzerland) — Principal investigator
First posted
May 14, 2024
Start date
Jul 3, 2020
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jul 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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