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Completed

NCT Number: NCT05727436

The Effect of Probiotics on Gingivitis

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.

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Key information

Conditions

Gingivitis; Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Gingival Diseases Gingivitis Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Mouth Diseases Organizing Pneumonia Periodontal Diseases Respiratory Tract Diseases Stomatognathic Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Dentistry of Sechenov University

Moscow, 121059, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dentoblis

Dietary Supplement

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

Other names: Probiotic: Streptococcus salivarius M18

Placebo

Dietary Supplement

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

    Time frame: 4 weeks after the baseline

    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.

  2. Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness

    Time frame: 8 weeks after the baseline

    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.

  3. Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975

    Time frame: 4 weeks after the baseline

    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. Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975

    Time frame: 8 weeks after the baseline

    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 outcomes

  1. Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index

    Time frame: 4 weeks after the baseline

    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.

  2. Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index

    Time frame: 8 weeks after the baseline

    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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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