The Effect of Probiotics on Gingivitis: Part 2

Not Applicable

Completed

• Conditions: Gingivitis; Chronic
• Interventions: Dietary Supplement: Dentoblis; Dietary Supplement: Placebo

• Registration Number: NCT05919134
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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.

Detailed 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).

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-20
• Study Start: 2023-04-24
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-26
• Primary Completion: 2023-09-20
• Study Completion: 2023-10-12
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - probiotic	Dentoblis	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.
Group 2 - placebo	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975	16 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
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness	16 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.

Secondary Outcome Measures

Name	Time	Method
Turesky Modification of the Quigley-Hein Plaque Index	16 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; 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

Trial Locations

Locations (1)

Institute of Dentistry of Sechenov University; 🇷🇺 Moscow, Russian Federation