SALI-10 probiotic lozenges for gingivitis and halitosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will evaluate the safety and potential benefit of SALI-10 probiotic lozenges compared with placebo in adults with gingivitis and halitosis. Participants will receive either the SALI-10 lozenge or placebo in a controlled setting to monitor oral health outcomes and any adverse effects. The trial will monitor plaque-related indices, gingival status, and self-reported breath quality to see if the probiotic strain can support gingival health and reduce halitosis. The approach leverages a Streptococcus salivarius strain that produces Salivaricin 10, thought to have antimicrobial and anti-inflammatory properties. The overall aim is to determine if this probiotic can safely contribute to improved oral health in the target population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. Non-smokers
4. Fluent in English
5. For sexually active volunteers of childbearing potential, one of the following methods must be used to prevent pregnancy during the study by participants.

   1. Post-menopausal
   2. hormonal birth control (oral, injectable, transdermal, intra-vaginal) or intrauterine device must be in use at least 30 days prior to first study drug administration;
   3. barrier methods must be in use at least 14 days prior to study drug administration;
   4. that vasectomy on the male partner must be completed 3 months prior to first study drug administration;
   5. or in the alternative that a 0 sperm count for the male partner will suffice

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Dental pain at time of screening.
4. History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study, or to any of the following: sorbitol, isomalt, dibasic calcium phosphate, potato or potato starch, mint or mint flavour, glyceryl dibehenate, steviol glycosides.
5. Participation in any other clinical study or test panel within one month before entering the study.
6. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
7. Those taking anticoagulant medications and have blood and bleeding disorders
8. Those who have recently experienced (past 30 days) or will be experiencing (next 90 days) dental, oral, or any type of surgery
9. History of systemic inflammatory or immune conditions or immunocompromised conditions
10. Pregnant or nursing women or those planning on getting pregnant.
11. Use of tobacco products.
12. Long-term antibiotic or anti-inflammatory therapy.
13. Medical condition or any current usage of medication that the investigator considers may compromise the subject's safety as well as the quality of the study results (note, only Advil and Tylenol are allowed during the study for analgesia)
14. Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.
15. Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.
16. Presence of active infections
17. Use of any probiotic
18. Use of anti-plaque/anti-gingivitis products
19. Subjects who must receive dental treatment during the study elates
20. Concurrent orthodontic treatment
21. Untreated carious lesions and/or inadequate restorations on maxillary posterior teeth
22. Periodontal disease (periodontal pockets, probing depth (PD) \< 3.0 mm on at least one tooth/site, presence of Clinical Attachment Loss (CAL) = 0 mm, or periodontal disease history)

Where it's running

• OMGPerio
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Alon Borenstein, MDM, M.Sc Periodontology — OMGPerio
• Study coordinator: Mark Kwiecinski, P.Eng, M.Sc Physics
• Email: Mark@PMKengineering.com
• Phone: 1-613-513-4413

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• Toothpaste for reducing dental plaque and preventing gum problems

  This study tests three toothpaste options to see if they reduce plaque and gingivitis in adults with mild gum inflammation.

  Recruiting Phase 3 Colgate Palmolive · Roma, Rome · NCT07842991

• Effect of stannous fluoride toothpaste on gingival health indicators in an experimental gingivitis model

  This study tests whether a toothpaste with stannous fluoride can influence gingival crevicular fluid biomarkers and help gingival tissue recover during early gingivitis.

  Recruiting Haleon · Birmingham · NCT07842042

• Toothpaste that may reduce plaque and gingivitis in Chinese adults

  A toothpaste test will be used to see if it reduces plaque and gingivitis more than a regular fluoride toothpaste in Chinese people with localized gingivitis.

  Recruiting Haleon · Shanghai, Shanghai Municipality · NCT07816406

• Safety and effectiveness of an electric flosser with a manual toothbrush for gingivitis and plaque

  This study tests whether using an electric interproximal flosser in addition to a manual toothbrush can reduce gingival inflammation and plaque in adults with gingivitis compared with brushing alone.

  Recruiting Flaus, Inc · Fort Wayne, Indiana · NCT07779564

• Bacterial Diversity in Gum Health With Fixed vs Removable Retainers After Braces

  This study tests the gum microbiome and gum health in adults after braces, comparing fixed lingual retainers to removable Essix retainers.

  Recruiting Universidad de Murcia · Murcia · NCT07718061

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.