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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05919134
Other study ID # 18081214
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2023
Est. completion date October 12, 2023

Study information

Verified date April 2023
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 12, 2023
Est. primary completion date September 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dentoblis
dissolve the tablets in the mouth once a day for 4 weeks
Placebo
dissolve the tablets in the mouth once a day for 4 weeks

Locations

Country Name City State
Russian Federation Institute of Dentistry of Sechenov University Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
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Completed NCT03455192 - Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis N/A
Completed NCT05727436 - The Effect of Probiotics on Gingivitis N/A