Assessing the Impact on dental biofilm of Heyndrickxia coagulans administered through sugar-free chewing gum

Assessing the Impact on dental biofilm of Heyndrickxia coagulans administered through sugar-free chewing gum: a double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13055033

Enrollment

Registered

2025-12-04

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change in dental plaque microflora after administration of probiotics in healthy adult patients Oral Health

Interventions

Participants will be randomized into two groups using a computer-generated randomization system. Both participants and investigators will be blinded to group allocation. All study participants will gi

subjects in the control arm will receive a placebo chewing gum, identical in appearance and composition to that of the intervention group but without the probiotic. The experimental period will be st

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Adult subjects aged 18 to 64 years 2. At least 24 natural teeth (excluding third molars) 3. Gingival index and plaque index scores = 2 4. Stimulated salivary flow rate between 1.5 and 2.0 mL/min.

Exclusion criteria

Exclusion criteria: 1. Presence of systemic diseases 2. Pregnancy or lactation 3. History of drug abuse 4. Smoking habits 5. Use of fixed orthodontic appliances 6. Allergies to any ingredients in the chewing gums used

Design outcomes

Primary

Measure	Time frame
The composition of the dental plaque microbial ecosystem is measured using metataxonomic analysis of 16S rRNA gene sequencing at T0, T2, and T3	—

Secondary

Measure	Time frame
1. Presence and quantity of H. coagulans SNZ1969® in dental plaque is measured using strain-specific qPCR at T0, T1, T2, and T3 in the intervention arm, and at T0 only in the control arm 2. Volatile sulphur compounds (VSCs) in exhaled breath are measured using a halimeter (OralChroma™) at T0, T1, T2, and T3 3. Halitosis status is measured using threshold values of H2S = 112 ppb and CH3SH = 26 ppb from halimeter readings at T0, T1, T2, and T3 4. Alpha diversity of the dental plaque microbiota is measured using observed features, Faith’s phylogenetic diversity, Pielou’s evenness, and Shannon entropy from QIIME 2™ analysis at T0, T2, and T3 5. Beta diversity of the dental plaque microbiota is measured using weighted UniFrac, unweighted UniFrac, Jaccard, and Bray–Curtis dissimilarity metrics from QIIME 2™ analysis at T0, T2, and T3 6. Differential abundance of bacterial taxa in dental plaque is measured using DESeq2 analysis of metataxonomic data at T0, T2, and T3	—

Measure

Time frame

1. Presence and quantity of *H. coagulans* SNZ1969® in dental plaque is measured using strain-specific qPCR at T0, T1, T2, and T3 in the intervention arm, and at T0 only in the control arm 2. Volatile sulphur compounds (VSCs) in exhaled breath are measured using a halimeter (OralChroma™) at T0, T1, T2, and T3 3. Halitosis status is measured using threshold values of H2S = 112 ppb and CH3SH = 26 ppb from halimeter readings at T0, T1, T2, and T3 4. Alpha diversity of the dental plaque microbiota is measured using observed features, Faith’s phylogenetic diversity, Pielou’s evenness, and Shannon entropy from QIIME 2™ analysis at T0, T2, and T3 5. Beta diversity of the dental plaque microbiota is measured using weighted UniFrac, unweighted UniFrac, Jaccard, and Bray–Curtis dissimilarity metrics from QIIME 2™ analysis at T0, T2, and T3 6. Differential abundance of bacterial taxa in dental plaque is measured using DESeq2 analysis of metataxonomic data at T0, T2, and T3

—

Countries

Italy

Contacts

Public ContactSilvia Cirio

silvia.cirio@unimi.it+39 3478436387

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026