The Effect of Probiotics on Gingivitis: Part 2

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Gingivitis; Chronic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dentoblis

Study type: Interventional

Funder types: Other

Identifiers

NCT05919134

18081214

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group 1 - probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dentoblis

Group 2 - placebo

Placebo Comparator group

Description:

The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing). Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring.

Treatment:

Dietary Supplement: Placebo