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Tests treatment safety and results for Gingivitis
Official title Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis
ClinicalTrials.gov ID: NCT07256743
What this study is testing
- What it's testing
- Gingivitis is among the most prevalent oral diseases worldwide, affecting an estimated 50-90% of adults. It is a reversible condition primarily caused by microbial plaque accumulation on teeth and gingival surfaces, which triggers inflammation.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Male or female volunteers aged 18-70 years
- In good general health, ASA I
- No clinical signs of gingival inflammation at \>90% of sites observed
- Absence of Periodontal Pockets, Probing Depth (PD) \< 3.0 mm on all teeth/site
- Absence of Clinical Attachment Loss (CAL) = 0 mm
You likely can't join if
- Presence of orthodontic bands.
- Presence of partial or full dentures.
- Tumour(s) of the soft or the hard tissues of the oral cavity.
- Cavitated carious lesions requiring immediate restorative treatment.
- History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
- Participation in any other clinical study or test panel within one month before entering the study.
See the full eligibility criteria
- Male or female volunteers aged 18-70 years
- In good general health, ASA I
- No clinical signs of gingival inflammation at \>90% of sites observed
- Absence of Periodontal Pockets, Probing Depth (PD) \< 3.0 mm on all teeth/site
- Absence of Clinical Attachment Loss (CAL) = 0 mm
- No periodontal disease history
- Have at least 20 gradeable teeth
- Non-smokers
- Fluent in English
- For study participants of childbearing potential, both men and women, at least one of the following birth control measures must be used: abstinence, hormonal birth control (oral, injectable, transdermal, intra-vaginal)...
- Presence of orthodontic bands.
- Presence of partial or full dentures.
- Tumour(s) of the soft or the hard tissues of the oral cavity.
- Cavitated carious lesions requiring immediate restorative treatment.
- History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
- Participation in any other clinical study or test panel within one month before entering the study.
- Medical condition which requires pre-medication before dental visits/procedures
- Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
- History of periodontal disease.
- History of systemic inflammatory, immune conditions and immunocompromised conditions
- Pregnant or nursing women or those planning to get pregnant
- Use of tobacco products.
- Long-term antibiotic or anti-inflammatory therapy.
- Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.
- Medical condition or any current usage of medication that the investigator considers may compromise the study participant's safety as well as the quality of the study results
- Allergy to any of the following ingredients: Streptococcus Salivarius, Sorbitol, Isomalt, Calcium phosphate dibasic, Potato starch, Mint, Glyceryl dibehenate, Stevia, Maltodextrin
- Use of other probiotics
- Taking anticoagulant medications and those suffering from blood and bleeding disorders
- Recently experienced or will be experiencing dental, oral or any type of surgery.
- Use of anti-plaque/ anti-gingivitis products
- Presence of active infections
- Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.
- Use of any antibiotics.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.