The Effect of Probiotics on Oral Health

NCT05039320 | Completed DMC

• 1 other identifier: 18081211
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a double-blind, randomized, placebo-controlled two-arm parallel groups study of the effect of oral probiotics containing Streptococcus salivarius K12 on oral biofilm, salivation rate, and secretory immunoglobulin A salivary level. The aim of the study is to assess the effect of oral probiotics containing Streptococcus salivarius K12 strain on oral biofilm, unstimulated salivary flow rate, and salivary secretory immunoglobulin A (sIgA) levels.

Conditions

Oral Disease

Keywords

probiotics; Streptococcus salivarius K12; dental biofilm; salivary secretory immunoglobulins A; unstimulated salivary flow rate

Outcome Measures

Primary Outcomes (4)

• Changes in the concentration of secretory immunoglobulin A in saliva

  Salivary secretory IgA levels are determined using the 8668 IgA secretory ELISA-BEST kit (VectorBest, Novosibirsk, Russia) based on a two-step "sandwich" version of the enzyme-linked immunosorbent assay (ELISA).

  4 weeks after the baseline

• Changes in the concentration of secretory immunoglobulin A in saliva

  Salivary secretory IgA levels are determined using the 8668 IgA secretory ELISA-BEST kit (VectorBest, Novosibirsk, Russia) based on a two-step "sandwich" version of the enzyme-linked immunosorbent assay (ELISA).

  6 weeks after the baseline

• Changes in the unstimulated salivary flow rate

  participants refrain from eating, drinking, smoking, or conducting oral hygiene for a minimum of 90 minutes prior to salivary collection. To avoid diurnal variations in saliva output, all measurements are taken in the morning. Participants are comfortably seated and, after a few minutes of relaxation, are trained to avoid swallowing saliva and asked to lean forward and spit all the saliva they produce every 2 minutes through a glass funnel and into a graduated test tube. The volume collected for 10 minutes is measured. The flow rate is determined according to the formula: Salivation rate(ml/min) = saliva volume(ml) / saliva collection time(min).

  4 weeks after the baseline

• Changes in the unstimulated salivary flow rate

  participants refrain from eating, drinking, smoking, or conducting oral hygiene for a minimum of 90 minutes prior to salivary collection. To avoid diurnal variations in saliva output, all measurements are taken in the morning. Participants are comfortably seated and, after a few minutes of relaxation, are trained to avoid swallowing saliva and asked to lean forward and spit all the saliva they produce every 2 minutes through a glass funnel and into a graduated test tube. The volume collected for 10 minutes is measured. The flow rate is determined according to the formula: Salivation rate(ml/min) = saliva volume(ml) / saliva collection time(min).

  6 weeks after the baseline

Secondary Outcomes (4)

• Turesky Modification of the Quigley-Hein Plaque Index

  4 weeks after the baseline

• Turesky Modification of the Quigley-Hein Plaque Index

  6 weeks after the baseline

• Papillary-marginal-alveolar index

  4 weeks after the baseline

• Papillary-marginal-alveolar index

  6 weeks after the baseline

Study Arms (2)

Group 1 - probiotic

EXPERIMENTAL

The use of Streptococcus salivarius K12 containing tablets ("Bactoblis", registration number: AM.01.06.01.003.Е.000024.07.18; 20.07.18, MEDICO DOMUS, d.d.o.; 18116, Nis, Serbia)) once a day for 4 weeks (before bedtime after evening brushing). Ingredients: basic active ingredient - Streptococcus salivarius K12 (≥1×109 CFU in 1 tablet), excipients - fructose (sweetener), maltodextrin, silicon dioxide, magnesium stearate (vegetable), strawberry flavouring.

Dietary Supplement: Bactoblis

Group 2 - placebo

PLACEBO COMPARATOR

The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing). Ingredients: fructose (sweetener), maltodextrin, silicon dioxide, magnesium stearate (vegetable), flavouring (strawberry).

Dietary Supplement: Placebo

Interventions

Bactoblis DIETARY_SUPPLEMENT

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

Also known as: Probiotic: Streptococcus salivarius K12

Group 1 - probiotic

Placebo DIETARY_SUPPLEMENT

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

Group 2 - placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Permanent bite;
• Presence of more than 20 teeth;
• Absence of systemic and chronic diseases.
• More than 5 cavities requiring treatment;
• Refusal to sign informed consent;
• Taking supplements and medication containing probiotics or prebiotics 3 weeks before the study;
• Taking antibiotics (within 1 month before the study);
• Orthodontic and prosthetic treatment;
• Allergy to the components of the drugs used in the study.

You may not qualify if:

• Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
• Refusal to take a given medication;
• Failure to attend check-ups.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• I. Mechnikov Research Institute of Vaccines and Sera: collaborator

Study Sites (1)

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

Location

Related Publications (2)

• Polyakova MA, Arakelyan MG, Babina KS, Margaryan EG, Sokhova IA, Doroshina VY, Novozhilova NE. Qualitative and Quantitative Assessment of Remineralizing Effect of Prophylactic Toothpaste Promoting Brushite Formation: A Randomized Clinical Trial. J Int Soc Prev Community Dent. 2020 May 7;10(3):359-367. doi: 10.4103/jispcd.JISPCD_493_19. eCollection 2020 May-Jun.

  PMID: 32802784 BACKGROUND

• 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.

  PMID: 35268099 DERIVED

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Ksenia Babina, PhD

  Sechenov University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 9, 2021
• Study Start: September 2, 2021
• Primary Completion: October 28, 2021
• Study Completion: November 4, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)