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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Institute of Dentistry of Sechenov University
Moscow, Russia
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 8 weeks after the baseline
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; 1. \- separate areas of plaque in the cervical part; 2. \- plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; 3. \- cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; 4. \- plaque covers 1/3 to 2/3 of the crown; 5. \- plaque covers more than 2/3 of the crown.
Time frame: 4 weeks after the baseline
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; 1. \- separate areas of plaque in the cervical part; 2. \- plaque in the form of a thin continuous band up to 1 mm wide in the cervical part; 3. \- cervical part is covered by plaque that is more than 1 mm wide, but less than 1/3 of the tooth crown; 4. \- plaque covers 1/3 to 2/3 of the crown; 5. \- plaque covers more than 2/3 of the crown.
Time frame: 8 weeks after the baseline