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NCT Number: NCT06411977

Effect of Dietary Supplements on the Oral Microbiome

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Nutrition, Healthy

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wuerzburg, Würzburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vegetable juice

Dietary Supplement

Vegetable juice (Fa. Fitrabbit, Voglsam)

Primary outcomes

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

    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)

    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.

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

    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)

    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

  3. Investigation of gingival indices using Sulcus Bleeding Index.

    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)

    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)

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

    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)

    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.

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

    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)

    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.

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

    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)

    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.

Sponsors and collaborators

Lead sponsor

University Center of Dental Medicine Switzerland

Other

Collaborators

  • Helmholtz Centre for Infection Research
  • University of Wuerzburg

Registry information

Official study title

Multiband-/-Bracket Induced Qualitative and Quantitative Changes in the Oral Microbiome and Its Influence by Preventive Intervention Using Dietary Supplements

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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