The Effect of Probiotics on Gingivitis

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• Gingivitis 590

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 61 is close to the median of 64 across 478 interventional studies indexed under Gingivitis.

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Study arms

• Experimental
  Group 1 - probiotic

  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.

  Dietary Supplement: Dentoblis

• Placebo comparator
  Group 2 - placebo

  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

Interventions

• Dietary supplementDentoblis

  Dissolve the tablets in the mouth once a day for 4 weeks

  Also known as: Probiotic: Streptococcus salivarius M18

• Dietary supplementPlacebo

  Dissolve the tablets in the mouth once a day for 4 weeks

Primary outcomes

1. 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

2. 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

3. 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: 4 weeks after the baseline

4. 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

Secondary outcomes

1. 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

2. 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

Publications

• 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. PubMed 35268099 ↗

Individual participant data

Plan to share: No