Clinical trial NCT06411977: Effect of Dietary Supplements on the Oral Microbiome
Official title: Multiband-/-Bracket Induced Qualitative and Quantitative Changes in the Oral Microbiome and Its Influence by Preventive Intervention Using Dietary Supplements
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: University Center of Dental Medicine Switzerland
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
name: Helmholtz Centre for Infection Research
First posted: 2024-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigation of gingival indices using Plaque Index (PI)
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
measure: Investigation of gingival indices using Periodontal Screening Index (PSI).
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
measure: Investigation of gingival indices using Sulcus Bleeding Index.
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
measure: To count the number of bacterial colonization on tongue using next-generation-sequencing of the bacterial 16S rRNA gene.
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
measure: To count the number of bacterial colonization in plaque using next-generation-sequencing of the bacterial 16S rRNA gene.
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
measure: To count the number of bacterial colonization in saliva using next-generation-sequencing of the bacterial 16S rRNA gene.
timeFrame: Baseline (before insertion of fixed orthodontic appliances) T0, two weeks after insertion of orthodontic appliances (T1), 3 months-6 months after baseline (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University of Wuerzburg
city: Basel
country: Switzerland
facility: University Center for Dental Medicine
Study officials:
References: