💬In plain words
What the trial is, and whether it could suit you
Gingivitis is among the most common oral conditions, affecting 50-90% of adults globally. It is a reversible inflammatory disease triggered primarily by the accumulation of microbial plaque on teeth and gingival tissues. Standard treatment involves plaque reduction and maintenance of oral hygiene, often supplemented with antimicrobial therapeutics to prevent disease progression. While plaque control remains the cornerstone of prevention, emerging research points to certain beneficial microbes that may protect gingival health. Notably, Streptococcus species have been associated with both antimicrobial and anti-inflammatory activities, suggesting their potential as oral probiotics.
Recent investigations have focused on a novel strain, Streptococcus salivarius SALI-10, which produces a lantibiotic called Salivaricin 10. This peptide exhibits unique immunomodulatory properties. In murine mo
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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