The Effect of Probiotics on Gingivitis: Part 2

Gingivitis; Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05919134
• Other study ID #: 18081214
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Gingivitis
• Gingivitis; Chronic

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