The Effect of Oral Probiotics (Streptococcus Salivarius K12) on Biofilm, Salivation, and Secretory Immunoglobulin A Salivary Level: a Pilot Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Changes in the concentration of secretory immunoglobulin A in saliva
Study Overview
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.
Detailed Description
Thirty consenting patients aged 20-24 years who will meet the inclusion criteria will be recruited in the study. At the preparatory phase patients will be recruited and randomized, their oral hygiene protocols will be standardized, researchers will be calibrated and trained. The main phase will include a double-blind, randomized, two-arm parallel group, placebo-controlled study of probiotics effects, and wash-out period. Patients will be randomly divided into 2 groups (group 1 - probiotics, group 2 - placebo). Clinical examination will be performed at baseline, after 4 weeks (probiotic/placebo intake) and 6 weeks (wash-out), and will include the assessment of DMFT index, oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI)), gingival inflammation (PMA index), salivation rate (unstimulated salivary flow), and salivary concentration of secretory immunoglobulins A.
The study is estimated to complete enrollment within 4 weeks from study initiation; however, enrollment will remain open until the study goal is met. The duration of this study for each subject will be a maximum of eight (10) weeks: 4 weeks - preparatory period, 4 weeks - intervention period, and wash out period (2 weeks).
Screening (First) visit
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Review the study with the subject and obtain written informed consent
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Assign the subject a unique screening/enrollment number
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Review and record medical history, and medication history to determine eligibility based on inclusion/exclusion criteria
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Record demographics (age, gender)
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Document vitals
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Document all current medications, including medications over-the-counter and herbal medications
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Perform physical examination
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Determine DMFT index
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Determine oral hygiene level (TQHPI)
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Provide training in standardised brushing techniques.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Permanent bite;
- •Presence of more than 20 teeth;
- •Absence of systemic and chronic diseases.
- •Non-inclusion Criteria:
- •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.
Exclusion Criteria
- •Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
- •Refusal to take a given medication;
- •Failure to attend check-ups.
Arms & Interventions
Group 1 - probiotic
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.
Intervention: Bactoblis (Dietary Supplement)
Group 2 - placebo
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).
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in the concentration of secretory immunoglobulin A in saliva
Time Frame: 6 weeks after the baseline
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).
Changes in the unstimulated salivary flow rate
Time Frame: 6 weeks after the baseline
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).
Changes in the concentration of secretory immunoglobulin A in saliva
Time Frame: 4 weeks after the baseline
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).
Changes in the unstimulated salivary flow rate
Time Frame: 4 weeks after the baseline
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).
Secondary Outcomes
- Turesky Modification of the Quigley-Hein Plaque Index(6 weeks after the baseline)
- Papillary-marginal-alveolar index(6 weeks after the baseline)
- Turesky Modification of the Quigley-Hein Plaque Index(4 weeks after the baseline)
- Papillary-marginal-alveolar index(4 weeks after the baseline)