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Not yet recruitingNCT06015958Updated Aug 29, 2023

Probiotic Toothpaste to Assess Microbial Colonization

An interventional study of Streptococcus salivarius M18 toothpaste (1 million cfu) and Streptococcus salivarius M18 toothpaste (10 million cfu) in Microbial Colonization, sponsored by BLIS Technologies Limited. Not yet recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by BLIS Technologies Limited · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

Read the detailed description

This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.

Participants will be randomly assigned to one of 2 groups for brushing teeth with a probiotic toothpaste containing two different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

02

Conditions studied

  • Microbial Colonization

Keywords

  • probiotic toothpaste
  • Streptococcus salivarius M18
  • Microbial colonization
  • Oral Probiotic
  • Toothpaste
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 20 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

BLIS Technologies Limited is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • In general good health
  • Practise good oral hygiene

Exclusion Criteria:-

  • Have a history of autoimmune disease or are immunocompromised.
  • Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
  • History of allergy (e.g. dairy).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Active Comparator: Streptococcus salivarius M18 toothpaste dose 1

    Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

    Other: Streptococcus salivarius M18 toothpaste (1 million cfu)

  • Active comparator
    Active Comparator: Streptococcus salivarius M18 toothpaste dose 2

    Streptococcus salivarius M18 toothpaste containing 10 million cfu/g

    Other: Streptococcus salivarius M18 toothpaste (10 million cfu)

Interventions

  • OtherStreptococcus salivarius M18 toothpaste (1 million cfu)

    Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.

  • OtherStreptococcus salivarius M18 toothpaste (10 million cfu)

    Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.

06

What researchers measure

Primary outcomes

  1. Change in Microbial colonization from baseline (Day 0) to 1 hour

    Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).

    Time frame: 1 hour post intervention

  2. Change in Microbial colonization from baseline (Day 0) to 8 hours

    Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).

    Time frame: 8 hours post intervention

  3. Change in Microbial colonization from baseline (Day 0) to 24 hours

    Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).

    Time frame: 24 hours post intervention

  4. Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose

    Study will determine the change in the microbial colonization efficacy of two different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).

    Time frame: 8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.

07

Study locations

1 site
  • Blis Technologies Ltd
    Dunedin, Otago 9012, New Zealand
08

References and documents

Publications

  • Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28. PubMed 23449874 ↗
  • Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359. PubMed 32099975 ↗
  • Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015. PubMed 26491371 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06015958
Lead sponsor
BLIS Technologies Limited
Responsible party
Sponsor
First posted
Aug 29, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Nov 29, 2023 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
Aug 29, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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