MedDataX Logo

The Effect of Probiotics on Gingivitis: Part 2

NCT ID: NCT05919134

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2023-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis; Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment double-blind, randomized, two-arm parallel-group study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 - probiotic

The use of Streptococcus salivarius M18 containing tablets ("Dentoblis", registration number: AM.01.06.01.003.R.000061.07.20; 15.07.2020, MEDICO DOMUS, d.d.o.; 18116, Nis, Serbia)) once a day for 4 weeks (before bedtime after evening brushing).

Ingredients: basic active ingredients - Streptococcus salivarius M18 (≥5×108 CFU in 1 tablet), Vitamin D (320 IU (8 mcg) in 1 tablet); excipients - isomalt (sweetener), magnesium stearate (vegetable), mint flavoring.

Group Type EXPERIMENTAL

Dentoblis

Intervention Type DIETARY_SUPPLEMENT

dissolve the tablets in the mouth once a day for 4 weeks

Group 2 - placebo

The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing).

Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

dissolve the tablets in the mouth once a day for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dentoblis

dissolve the tablets in the mouth once a day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

dissolve the tablets in the mouth once a day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Probiotic: Streptococcus salivarius M18

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Dentistry of Sechenov University

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35268099 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18081214

Identifier Type: -

Identifier Source: org_study_id