Effect of Dietary Supplements on the Oral Microbiome

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: Vegetable juice

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.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Reichardt, Dr.; Phone Number: 00493641448392; Email: elisabeth.reichardt@unibas.ch

Study Locations

• Germany
  • Würzburg, Germany
    • Recruiting
    • University of Wuerzburg
    • Contact: Elisabeth Reichardt, Dr.
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Center for Dental Medicine
    • Contact: Elisabeth Reichardt, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Vegetable juice (Fa. Fitrabbit, Voglsam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
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	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
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)	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
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.	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
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.	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
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.	Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)

Collaborators and Investigators

• Sponsor: University Center of Dental Medicine Switzerland
• Collaborators: University of Wuerzburg; Helmholtz Centre for Infection Research

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019-01896

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No