Gingivitis; ChronicNCT05727436
The Effect of Probiotics on Gingivitis
A study testing Dentoblis in people with Gingivitis; Chronic, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Gingivitis; Chronic
- What is being tested?
- Dentoblis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteRussia
- Study dates
- 20 Feb 2023to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
- Refusal to take a given medication;
- Failure to attend check-ups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: A Randomized Clinical Trial
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.
Read the 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 index, GI; gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).
- Conditions
- Gingivitis; Chronic
- Being tested
- Dentoblis, Placebo
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentoblisDietary supplement
Also called Probiotic: Streptococcus salivarius M18
Dissolve the tablets in the mouth once a day for 4 weeks
PlaceboDietary supplement
Dissolve the tablets in the mouth once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - probiotic | Experimental | 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. Receives: Dietary Supplement: Dentoblis |
| Group 2 - placebo | Placebo comparator | The use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing).
Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks after the baseline
Secondary outcomes (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;
- - 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.
Measured: 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;
- - 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.
Measured: 8 weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start20 Feb 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingivitis; ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment double-blind, randomized, two-arm parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727436
- Sponsor's protocol ID
- 18081213
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35268099Babina K, Salikhova D, Doroshina V, Makeeva I, Zaytsev A, Uvarichev M, Polyakova M, Novozhilova N. Antigingivitis and Antiplaque Effects of Oral Probiotic Containing the Streptococcus salivarius M18 Strain: A Randomized Clinical Trial. Nutrients. 2023 Sep 6;15(18):3882. doi: 10.3390/nu15183882.
PubMed 37764667
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05727436
- Acronym / sponsor ID
- 18081213
- Conditions
- Gingivitis; Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 index, GI; gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment double-blind, randomized, two-arm parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Group 1 - probiotic | Experimental | Dietary Supplement: DentoblisExperimental: 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. |
| Group 2 - placebo | Placebo comparator | Dietary Supplement: PlaceboThe use of placebo tablets once a day for 4 weeks (before bedtime after evening brushing). Ingredients: isomalt (sweetener), magnesium stearate (vegetable), mint flavoring. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DentoblisAlso: Probiotic: Streptococcus salivarius M18Dissolve the tablets in the mouth once a day for 4 weeks | Dietary supplement | Group 1 - probiotic |
| PlaceboDissolve the tablets in the mouth once a day for 4 weeks | Dietary supplement | Group 2 - placebo |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index
Time frame: 4 weeks after the baseline
Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index
Time frame: 8 weeks after the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 35268099Babina 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.
- Derived from this study: PubMed 37764667Babina K, Salikhova D, Doroshina V, Makeeva I, Zaytsev A, Uvarichev M, Polyakova M, Novozhilova N. Antigingivitis and Antiplaque Effects of Oral Probiotic Containing the Streptococcus salivarius M18 Strain: A Randomized Clinical Trial. Nutrients. 2023 Sep 6;15(18):3882. doi: 10.3390/nu15183882.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dentoblis in people with Gingivitis; Chronic, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness (time frame: 4 weeks after the baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.