The Effect of a Postbiotic on Oral Health in Healthy Adults
ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Archer-Daniels-Midland Company
About this trial
The goal of this randomised, placebo-controlled trial is to determine the effect of a chewable postbiotic tablet on the oral health of male and female healthy adults under conditions of short term oral-neglect (a short, temporary period during which participants do not perform their usual oral hygiene practices, such as tooth brushing and flossing).
The main questions the study aims to answer are:
1. Does postbiotic ingestion impact dental plaque accumulation, gingival (gum) inflammation, and periodontal health compared with placebo? 2. Does postbiotic ingestion alter the oral microbiome composition compared with placebo?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults who are between 18 - 65 years of age (inclusive) at the time of signing the informed consent.
In otherwise good general health, as deemed by the investigator (based on review of medical history, vital signs, and physical examination performed at screening and/or before the first dose of the study product).
Are able to consume the study product completely within the specified timeframe.
Have a body mass index (BMI) between 18.5 to 29.9 kg/m² (inclusive).
Disqualifiers
Individuals who are intending to breastfeed, intending to conceive, or are pregnant as confirmed by a positive pregnancy test during study visits.
Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
Have periodontal probing depths of ≥4 mm at any site at the screening visit.
Have treatment-requiring oral diseases, including dental caries, gingivitis, or periodontitis.
Trial design
Design model
Parallel
Treatments tested in this trial
Postbiotic
Dietary supplement1 tablet to be taken after brushing in the morning and 1 tablet to be taken after brushing in the evening for 6 weeks. Tablets should be chewed until fully dissolved. The active intervention provides 10mg of heat-treated postbiotic per day. The postbiotic is manufactured by heat treatment of a probiotic preparation equivalent to 3.0 × 10\^9 CFU.
Placebo
Dietary supplement1 tablet to be taken after brushing in the morning and 1 tablet to be taken after brushing in the evening for 6 weeks. Tablets should be chewed until fully dissolved. The placebo tablet is matched to the active tablet in packaging, appearance, and taste.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: PostbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To determine the effect of the postbiotic on dental plaque formation compared to placebo
The difference between postbiotic and placebo in change from Baseline to Week 4 in dental plaque score as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI; range: 0 to 5, with lower scores indicating less plaque accumulation and a better outcome).
Time frame
Baseline and 4 weeksSecondary outcomes
1
To evaluate the effect of the postbiotic on dental plaque formation compared to placebo
Change in dental plaque formation as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI; range: 0 to 5, with lower scores indicating less plaque accumulation and a better outcome).
Time frame
Baseline to Week 2 and Week 6; Week 2 to Week 4 and Week 6; Week 4 to Week 62
To evaluate the effect of the postbiotic on dental calculus formation compared to placebo
Change in dental calculus formation as measured by the Volpe-Manhold Index (VMI; units: mm, with lower scores indicating less calculus accumulation and a better outcome).
Time frame
Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 63
To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as measured by an objective clinical assessment
Change in gingival bleeding assessed by bleeding on probing (BOP), measured using the Ainamo and Bay method and defined as the % of sites with bleeding on probing out of the total number of sites examined (units: %, with range 0 to 100 % and lower percentages indicating a lower prevalence of gingival bleeding and a better outcome).
Time frame
Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 64
To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as assessed through participant self-report
Change in participant-reported gingival bleeding, measured using the Gingival Bleeding Self-Assessment Questionnaire (GBSAQ; lower scores indicate less gingival bleeding and a better outcome).
Time frame
Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6Other outcomes
1
Change in oral microbiome composition following postbiotic intervention compared with placebo
To evaluate the effect of the postbiotic compared with placebo on oral microbiome composition, as measured by changes in alpha diversity and beta diversity over time.
Time frame
Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 62
Change in the abundance of beneficial versus pathogenic oral bacterial species following postbiotic intervention compared with placebo
To evaluate the effect of the postbiotic compared with placebo on the abundance of beneficial versus pathogenic oral bacterial species over time. Significant changes will be reported using fold change and adjusted p-values.
Time frame
Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 63
Changes in the abundances of oral microbial genes contained in specific functional modules following postbiotic intervention compared with placebo
To evaluate the effect of the postbiotic compared with placebo on changes in the abundance of genes within specific functional modules defined by the KEGG database. Gene Set Enrichment Analysis (GSEA) will be performed to determine which modules are enriched by the postbiotic throughout the study. Significant associations will be reported with the Normalized Enrichment score (NES) and adjusted p-values.
Time frame
Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 64
To evaluate the effect of the postbiotic on Streptococcus mutans counts compared to placebo
Change in S. mutans counts
Time frame
Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Archer-Daniels-Midland Company
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov
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