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An in vivo pilot study on permanence in saliva of two different probiotics strain administered through chewing gums

In vivo pilot randomized cross-over study on permanence in saliva of two different probiotics strain administered through chewing gums on healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11337204
Enrollment
10
Registered
2025-01-27
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Prevention and reduction of gingivitis and halitosis in healthy adult Oral Health

Interventions

This study is a randomized, cross-over pilot experiment on 10 subjects. Each subject tested one chewing gum and, after a washout period of one week, another chewing gum containing a different strain,

Sponsors

University of Milan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. The 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

MeasureTime frame
Viable bacterial cells in saliva measured using dilution plating onto selective media to count colony-forming units per 1 mL of culture (CFUs/mL) before chewing gum use (T0), and at 1, 5, 10, and 20 min, as well as 1 and 2 h after the procedure began (T1–T6). For H. coagulans SNZ1969, part of the samples underwent viable count after pasteurization (incubation in a water bath at 90 °C for 10 min) to quantify bacterial spores.

Secondary

MeasureTime frame
Adverse effects reported by participants measured by an investigator who conducted brief telephone interviews with the participants on the evening of the intervention day and one week later to record any side effects associated with the chewing gum administered

Countries

Italy

Contacts

Public ContactClaudia Salerno
claudia.salerno@ymail.com+39 02 50319008

Outcome results

None listed

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