60 Participants NeededMy employer runs this trial

SALI-10 Probiotic Lozenges for Gum Disease

MK
Overseen ByMark Kwiecinski, P.Eng, M.Sc Physics

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new probiotic lozenge that may help treat gum disease, specifically gingivitis. Researchers aim to determine if the lozenge, containing a special strain of bacteria called Streptococcus salivarius SALI-10, can reduce gum inflammation and improve oral health. Participants will receive either the lozenge with the active ingredient or a placebo, which is a sugar pill that looks the same but contains no active ingredient. Individuals who have had gingivitis, experience frequent gum inflammation, and do not use tobacco or have other oral issues might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for gum disease.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. The trial excludes participants who are currently using anti-inflammatory, antibiotics, or antimicrobial drugs, as well as those on long-term antibiotic or anti-inflammatory therapy. Only Advil and Tylenol are allowed for pain relief during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Streptococcus salivarius SALI-10 is generally safe for people. Research indicates that this probiotic, used in lozenges, is well-tolerated. In past studies, participants did not experience any major side effects when using these lozenges. Designed to help manage gum disease, they balance the bacteria in the mouth. The treatment aims to reduce gum swelling and support oral health. Overall, the safety data is promising, suggesting that SALI-10 lozenges could be a safe choice for improving gum health.12345

Why are researchers excited about this trial?

Unlike the standard treatments for gum disease, which usually involve scaling and root planing or antimicrobial treatments, SALI-10 Probiotic Lozenges work by introducing beneficial bacteria directly to the mouth. These lozenges contain 3 billion CFUs of the probiotic strain SALI-10, which aims to balance the oral microbiome and reduce harmful bacteria that cause gum disease. This innovative approach not only targets the root cause by restoring healthy bacteria but also offers a convenient, non-invasive delivery method, making it an exciting potential option for maintaining oral health. Researchers are particularly enthusiastic because this could provide a natural and effective alternative to traditional treatments.

What evidence suggests that SALI-10 Probiotic Lozenges might be an effective treatment for gum disease?

Studies have shown that probiotic lozenges can effectively reduce gum inflammation and improve oral health. In this trial, participants will receive either SALI-10 Probiotic Lozenges or a placebo. The new strain, Streptococcus salivarius SALI-10, shows promise in fighting inflammation and harmful bacteria. Research indicates that SALI-10 produces a special compound that controls bad bacteria and reduces gum swelling. In studies with mice, SALI-10 also boosted important immune responses needed for healing. This suggests that SALI-10 may help maintain a healthy balance of bacteria in the mouth and could support gum health alongside regular brushing and flossing.13678

Who Is on the Research Team?

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Dr. Alon Borenstein, MDM, M.Sc Periodontology

Principal Investigator

OMGPerio

Are You a Good Fit for This Trial?

This trial is for healthy, non-smoking adults aged 18-70 who speak English. Participants must use reliable birth control if they could become pregnant or have partners who could. People with serious health issues or smokers cannot join.

Inclusion Criteria

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;
My male partner had a vasectomy at least 3 months before I started the study drug.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks
1 visit (in-person)

Treatment

Participants receive twice-daily lozenges containing S. salivarius SALI-10 or placebo for 4 weeks

4 weeks
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • SALI-10 Probiotic Lozenges

Trial Overview

The study tests SALI-10 probiotic lozenges (containing Streptococcus salivarius SALI-10) taken twice daily after brushing and tongue scraping for four weeks, compared to a placebo lozenge, to see if it helps with gum disease and bad breath.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: SALI-10Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ostia Sciences

Lead Sponsor

Trials
1
Recruited
10+

Citations

Effectiveness of Probiotic Lozenges in Periodontal ... - PMC

The statistical analysis demonstrated a significant decrease in the periodontal parameters after the nonsurgical periodontal treatment with or without probiotic ...

Evaluation of the Safety and Efficacy of SALI-10 Probiotic ...

Its hypothesized benefits include reducing inflammation via promotion of the M2 macrophage phenotype, suppressing periopathogen growth through competitive ...

SALI-10 Oral Probiotics for Gum Disease

This trial tests a new oral probiotic called SALI-10 to determine its effectiveness in preventing gum disease, specifically gingivitis.

Effectiveness of Probiotic Lozenges in Periodontal ...

Objective The main purpose of this article was to evaluate the effect of probiotics used as an adjunctive to scaling and root planing (SRP) ...

Clinical and microbiological effects of probiotic lozenges in ...

L. reuteri-containing lozenges may be a useful adjuvant agent to slow re-colonization and improve clinical outcomes of chronic periodontitis.

SALI-10 Probiotic Lozenges for Gum Disease

This N/A medical study run by Ostia Sciences needs participants to evaluate whether SALI-10 Probiotic Lozenges will have tolerable side ...

SALI-10 Probiotic Lozenges for Gingivitis Prevention

This study investigates a new approach to help prevent and manage gingivitis, a common gum disease caused by the buildup of dental plaque.

Study Details | NCT07443410 | Microbiological and ...

Key exclusions include pregnancy or breastfeeding; recent antibiotic use; recent use of pre-/probiotic supplements; recent subgingival instrumentation; ...