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?
Participants will attend clinic visits at the beginning of the study and at weeks 2, 4, and 6. During these visits, examinations will be performed to assess the health of their teeth and gingivae (gums). Saliva and plaque samples will also be collected to investigate how the postbiotic may affect the oral microbiome (the bacteria that naturally live in the mouth).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
56
1 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.
1 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.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Guelph, Ontario, Canada
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 weeks
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 6
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 6
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 6
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 6
To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by probing pocket depth (PPD)
Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring Probing Pocket Depth (PPD), summarized as the % of sites with PPD ≥ 4 mm and ≥ 5 mm (units: %, range 0 to 100%, with lower percentages indicating a lower prevalence of periodontal pockets 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 6
To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by gingival recession
Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring gingival recession (units: mm, lower values indicate less gingival recession 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 6
To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by Clinical Attachment Level (CAL)
Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring Clinical Attachment Level (CAL; units: mm, lower values indicate less periodontal attachment loss 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 6
To evaluate the effect of the postbiotic on gingival inflammation compared to placebo
Change in gingival inflammation as measured by the Löe-Silness Gingival Index (GI; range 0 to 3, with lower scores indicating lower severity of gingival inflammation 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 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.