The Effect of Probiotics on Gingivitis: Part 2

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: a Randomized Clinical Trial: Part 2

Conditions
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Gingivitis; Chronic

Intervention / Treatment
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* Dietary Supplement: Dentoblis
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment double-blind, randomized, two-arm parallel-group study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - probiotic<br>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. | Dietary Supplement: Dentoblis<br>* dissolve the tablets in the mouth once a day for 4 weeks<br>* Other names: Probiotic: Streptococcus salivarius M18;|
| Placebo Comparator: Group 2 - placebo<br>The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing). Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring. | Dietary Supplement: Placebo<br>* dissolve the tablets in the mouth once a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness | GI is used to assess visual symptoms of gingivitis on mesial, distal, vestibular, and oral areas of each scorable tooth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4). Each area is given a score from 0 to 3. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-3). Scoring is performed using standard dental light: 0 = absence of inflammation; 1 = mild inflammation - slight change in color and little change in texture; 2 = moderate inflammation - moderate glazing, redness, oedema, and hypertrophy, bleeding on pressure; 3 = severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Lower scores indicate better results. | 4 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness | GI is used to assess visual symptoms of gingivitis on mesial, distal, vestibular, and oral areas of each scorable tooth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4). Each area is given a score from 0 to 3. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-3). Scoring is performed using standard dental light: 0 = absence of inflammation; 1 = mild inflammation - slight change in color and little change in texture; 2 = moderate inflammation - moderate glazing, redness, oedema, and hypertrophy, bleeding on pressure; 3 = severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Lower scores indicate better results. | 8 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness | GI is used to assess visual symptoms of gingivitis on mesial, distal, vestibular, and oral areas of each scorable tooth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4). Each area is given a score from 0 to 3. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-3). Scoring is performed using standard dental light: 0 = absence of inflammation; 1 = mild inflammation - slight change in color and little change in texture; 2 = moderate inflammation - moderate glazing, redness, oedema, and hypertrophy, bleeding on pressure; 3 = severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Lower scores indicate better results. | 12 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness | GI is used to assess visual symptoms of gingivitis on mesial, distal, vestibular, and oral areas of each scorable tooth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4). Each area is given a score from 0 to 3. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-3). Scoring is performed using standard dental light: 0 = absence of inflammation; 1 = mild inflammation - slight change in color and little change in texture; 2 = moderate inflammation - moderate glazing, redness, oedema, and hypertrophy, bleeding on pressure; 3 = severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Lower scores indicate better results. | 16 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975 | GBI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on mesial, distal, vestibular, and oral areas of each scorable tooth (whole mouth). Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-1). BI score:0=no bleeding after 10 sec, 1=bleeding upon probing after 10 sec or immediate bleeding. Lower scores indicate better results | 4 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975 | GBI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on mesial, distal, vestibular, and oral areas of each scorable tooth (whole mouth). Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-1). BI score:0=no bleeding after 10 sec, 1=bleeding upon probing after 10 sec or immediate bleeding. Lower scores indicate better results | 8 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975 | GBI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on mesial, distal, vestibular, and oral areas of each scorable tooth (whole mouth). Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-1). BI score:0=no bleeding after 10 sec, 1=bleeding upon probing after 10 sec or immediate bleeding. Lower scores indicate better results | 12 weeks after the baseline | 
| Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975 | GBI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on mesial, distal, vestibular, and oral areas of each scorable tooth (whole mouth). Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-1). BI score:0=no bleeding after 10 sec, 1=bleeding upon probing after 10 sec or immediate bleeding. Lower scores indicate better results | 16 weeks after the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turesky Modification of the Quigley-Hein Plaque Index | A plaque detection solution is used to detect the presence of plaque on both the vestibular and oral surfaces of all teeth except the third molars. Each surface is divided into 3 segments: mesial, central and distal. Thus, 6 segments are evaluated for each tooth. Evaluation criteria: 0 - no staining; - separate areas of plaque in the cervical part; - plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; - cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; - plaque covers 1/3 to 2/3 of the crown; - plaque covers more than 2/3 of the crown | 4 weeks after the baseline | 
| Turesky Modification of the Quigley-Hein Plaque Index | A plaque detection solution is used to detect the presence of plaque on both the vestibular and oral surfaces of all teeth except the third molars. Each surface is divided into 3 segments: mesial, central and distal. Thus, 6 segments are evaluated for each tooth. Evaluation criteria: 0 - no staining; - separate areas of plaque in the cervical part; - plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; - cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; - plaque covers 1/3 to 2/3 of the crown; - plaque covers more than 2/3 of the crown | 8 weeks after the baseline | 
| Turesky Modification of the Quigley-Hein Plaque Index | A plaque detection solution is used to detect the presence of plaque on both the vestibular and oral surfaces of all teeth except the third molars. Each surface is divided into 3 segments: mesial, central and distal. Thus, 6 segments are evaluated for each tooth. Evaluation criteria: 0 - no staining; - separate areas of plaque in the cervical part; - plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; - cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; - plaque covers 1/3 to 2/3 of the crown; - plaque covers more than 2/3 of the crown | 12 weeks after the baseline | 
| Turesky Modification of the Quigley-Hein Plaque Index | A plaque detection solution is used to detect the presence of plaque on both the vestibular and oral surfaces of all teeth except the third molars. Each surface is divided into 3 segments: mesial, central and distal. Thus, 6 segments are evaluated for each tooth. Evaluation criteria: 0 - no staining; - separate areas of plaque in the cervical part; - plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; - cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; - plaque covers 1/3 to 2/3 of the crown; - plaque covers more than 2/3 of the crown | 16 weeks after the baseline |