The Effect of Probiotics on Gingivitis: Part 2 (NCT05919134) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Probiotics on Gingivitis: Part 2
Russia60 participantsStarted 2023-04-24
Plain-language summary
The aim of the study is to assess the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene in young adults.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18-25 years
* Permanent bite;
* Presence of more than 20 teeth;
* Absence of systemic and chronic diseases;
* The diagnosis of gingivitis stated clinically.
Exclusion Criteria:
* Presence of mild, moderate or severe chronic periodontitis;
* Refusal to sign informed consent;
* Taking supplements and medication containing probiotics or prebiotics 1 months before the study;
* Taking antibiotics (within 3 months before the study);
* Allergy to the components of the drugs used in the study;
* Presence of immunodeficiency, taking immunosuppressants.
* Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
* Refusal to take a given medication;
* Failure to attend check-ups.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Timeframe: 4 weeks after the baseline
2
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Timeframe: 8 weeks after the baseline
3
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Timeframe: 12 weeks after the baseline
4
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Timeframe: 16 weeks after the baseline
5
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
Timeframe: 4 weeks after the baseline
6
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
Timeframe: 8 weeks after the baseline
7
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
Trial details
NCT IDNCT05919134
SponsorI.M. Sechenov First Moscow State Medical University