Effect of Dietary Supplements on the Oral Microbiome

NCT ID: NCT06411977

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Orthodontic patients with fixed appliances

Group Type NO_INTERVENTION

No interventions assigned to this group

Juice group

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

Group Type OTHER

Vegetable juice

Intervention Type DIETARY_SUPPLEMENT

Vegetable juice (Fa. Fitrabbit, Voglsam)

Interventions

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Vegetable juice

Vegetable juice (Fa. Fitrabbit, Voglsam)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role collaborator

Helmholtz Centre for Infection Research

OTHER

Sponsor Role collaborator

University Center of Dental Medicine Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Dr. Elisabeth Reichardt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Wuerzburg

Würzburg, , Germany

Site Status

University Center for Dental Medicine

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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2019-01896

Identifier Type: -

Identifier Source: org_study_id

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