Clinical trial NCT05919134: The Effect of Probiotics on Gingivitis: Part 2
Official title: The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: a Randomized Clinical Trial: Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis; Chronic
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment double-blind, randomized, two-arm parallel-group study
Primary purpose: TREATMENT

Brief 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.

Detailed description: This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess the effect of oral probiotics, the following parameters will be used: gingival health (gingival index, GI; gingival bleeding index, GBI) and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
timeFrame: 4 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
timeFrame: 8 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
timeFrame: 12 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
timeFrame: 16 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
timeFrame: 4 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
timeFrame: 8 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
timeFrame: 12 weeks after the baseline
measure: Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
timeFrame: 16 weeks after the baseline
Secondary outcomes:
measure: Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: 4 weeks after the baseline
measure: Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: 8 weeks after the baseline
measure: Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: 12 weeks after the baseline
measure: Turesky Modification of the Quigley-Hein Plaque Index
timeFrame: 16 weeks after the baseline
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Dentistry of Sechenov University
Study officials:
References:
citation: Babina K, Salikhova D, Polyakova M, Svitich O, Samoylikov R, Ahmad El-Abed S, Zaytsev A, Novozhilova N. The Effect of Oral Probiotics (Streptococcus Salivarius k12) on the Salivary Level of Secretory Immunoglobulin A, Salivation Rate, and Oral Biofilm: A Pilot Randomized Clinical Trial. Nutrients. 2022 Mar 7;14(5):1124. doi: 10.3390/nu14051124.