Back to resultsThe Effect of Probiotics on Gingivitis
Primary Purpose
Gingivitis; Chronic
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Dentoblis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis; Chronic
Eligibility Criteria
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.
Sites / Locations
- Institute of Dentistry of Sechenov University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1 - probiotic
Group 2 - placebo
Arm Description
Experimental: 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.
The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing). Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Evaluation of oral hygiene using 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.
Evaluation of oral hygiene using 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.
Full Information
NCT ID
NCT05727436
First Posted
February 5, 2023
Last Updated
June 22, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05727436
Brief Title
The Effect of Probiotics on Gingivitis
Official Title
The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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 index, GI; gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis; Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment double-blind, randomized, two-arm parallel-group study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The allocation concealment will be performed by the use of sealed containers numbered by a "third party" (person, who will not participate in the study). The tablets in the bottles without any titles will be placed in the containers. The tablets in different groups will look similar. The patient on enrollment will receive a container with tablets. Each patient will receive a sealed container with tablets on enrollment. Neither patients nor researchers will be aware of the type of a tablets received by each patient (double blinding).
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - probiotic
Arm Type
Experimental
Arm Description
Experimental: 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.
Arm Title
Group 2 - placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dentoblis
Other Intervention Name(s)
Probiotic: Streptococcus salivarius M18
Intervention Description
Dissolve the tablets in the mouth once a day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Dissolve the tablets in the mouth once a day for 4 weeks
Primary Outcome Measure Information:
Title
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Description
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.
Time Frame
4 weeks after the baseline
Title
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
Description
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.
Time Frame
8 weeks after the baseline
Title
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
Description
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.
Time Frame
4 weeks after the baseline
Title
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
Description
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.
Time Frame
8 weeks after the baseline
Secondary Outcome Measure Information:
Title
Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index
Description
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.
Time Frame
4 weeks after the baseline
Title
Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index
Description
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.
Time Frame
8 weeks after the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Dentistry of Sechenov University
City
Moscow
ZIP/Postal Code
121059
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35268099
Citation
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.
Results Reference
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The Effect of Probiotics on Gingivitis
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