Effect of Dietary Supplements on the Oral Microbiome

NCT06411977 | Active Not Recruiting DMC

• 1 other identifier: 2019-01896
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

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.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Control group

NO INTERVENTION

Orthodontic patients with fixed appliances

Juice group

OTHER

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

Dietary Supplement: Vegetable juice

Interventions

Vegetable juice DIETARY_SUPPLEMENT

Vegetable juice (Fa. Fitrabbit, Voglsam)

Juice group

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 12 to 99 years
• Good general condition, healthy
• Inflammation-free marginal periodontium
• Metal brackets in the upper and lower jaw

You may not qualify if:

• 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

Sponsors & Collaborators

• University Center of Dental Medicine Switzerland: lead
• University of Wuerzburg: collaborator
• Helmholtz Centre for Infection Research: collaborator

Study Sites (2)

University of Wuerzburg

Würzburg, Germany

Location

University Center for Dental Medicine

Basel, Switzerland

Location

MeSH Terms

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 14, 2024
• Study Start: July 3, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

DE (1); CH (1)