Oral HealthLBOH-RCTNCT06457724
Levilactobacillus Brevis Oral Health
A study testing Levilactobacillus brevis CNCM I-5566 in people with Oral Health and Oral Disease, run by University of L'Aquila at 1 site in Italy.
Trial summary
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Oral Disease
- What is being tested?
- Levilactobacillus brevis CNCM I-5566
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2022to 30 Nov 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers of both sexes.
- Dental caries experience (DMFT) less than 4.
Who cannot join
- Active or historical periodontitis.
- Diabetes mellitus diagnosis.
- Active or historical cancer diagnosis.
- Antibiotic therapy within the past 3 months.
- Currently undergoing active therapy with drugs.
- Presence of disabilities affecting the ability to maintain oral hygiene at home.
Show all 9Show fewer
- Recent professional oral hygiene treatment within the last 3 months.
- Pregnancy.
- Presence of eating disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Effect of Levilactobacillus Brevis (CNCM I-5566) Probiotic Supplement on Clinical and Salivary Oral Indicators
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. The primary objective is to assess changes in salivary biomarkers, including salivary pH and buffer capacity; microbial composition using microbiome next-generation sequencing (NGS); and clinical oral inflammatory markers, such as full mouth bleeding score and full mouth plaque score, over a 4-week period. By comparing these indicators between the two groups, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases.
Read the detailed description
This RCT is designed to investigate the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. The study aims to provide robust evidence on the efficacy of this probiotic in promoting oral health and potentially preventing oral diseases.
Study Design:
Participants will be randomly assigned to one of two groups: the experimental group, which will receive the Levilactobacillus brevis CNCM I-5566 probiotic supplement, and the control group, which will receive a placebo. This random assignment ensures that the groups are comparable at the start of the trial, allowing for unbiased comparison of outcomes.
Duration:
The study will be conducted over a 4-week treatment period, during which participants will adhere to their assigned supplement regimen.
Primary Objectives:
The primary objective of this RCT is to assess the impact of Levilactobacillus brevis CNCM I-5566 on several key indicators of oral health, measured through salivary biomarkers, microbial composition, and clinical oral inflammatory markers.
Salivary Biomarkers:
Salivary pH: The acidity or alkalinity of saliva, which can influence oral health by affecting the growth of bacteria and the integrity of tooth enamel.
Buffer Capacity: The ability of saliva to neutralize acids, which is crucial for maintaining a healthy oral environment and preventing dental caries.
Salivation rate: The amount of salivary production (mL) overtime (in 5 minutes). This parameter is needed for individual caries risk assessment.
Microbial Composition:
The composition of the oral microbiome will be analyzed using next-generation sequencing (NGS). This advanced technique allows for a comprehensive assessment of the microbial populations present in the saliva and dental plaque, providing insights into how the probiotic supplement may alter the microbiome to support oral health.
Clinical Oral Inflammatory Markers:
Full Mouth Bleeding Score: A measure of gum inflammation and bleeding, which are indicators of gingivitis or periodontal disease.
Full Mouth Plaque Score: A measure of the accumulation of dental plaque, which is a biofilm of bacteria that can lead to tooth decay and gum disease if not properly managed.
Outcome Comparison:
By comparing the changes in these indicators between the probiotic supplement group and the placebo group, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566. Significant improvements in the probiotic group compared to the placebo group would suggest that Levilactobacillus brevis CNCM I-5566 is effective in promoting oral health and preventing oral diseases.
Significance:
This study has the potential to contribute valuable information to the field of oral health, particularly in understanding how probiotics can be used as a preventive measure against oral diseases. If successful, the findings could lead to new recommendations for probiotic use in dental care routines.
- Conditions
- Oral Health, Oral Disease
- Being tested
- Levilactobacillus brevis CNCM I-5566, Placebo
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levilactobacillus brevis CNCM I-5566Dietary supplement
Also called Mucomixx
Participants will take four Mucomixx tablets (containing Levilactobacillus brevis CNCM I-5566) daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner.
PlaceboDietary supplement
Participants will take four placebo tablets daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner.
| Study group | Role | What they receive |
|---|---|---|
| L. brevis | Experimental | Not described Receives: Dietary Supplement: Levilactobacillus brevis CNCM I-5566 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary pH
Assay used to define dental caries risk
Measured: Baseline, 4 and 6 weeks
Full mouth bleeding score
Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)
Measured: Baseline, 4 and 6 weeks
Full mouth plauqe score
Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)
Measured: Baseline, 4 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start30 Oct 2022
- Primary completion30 May 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Pietropaoli, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457724
- Sponsor's protocol ID
- 48/2022
- Acronym
- LBOH-RCT
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altamura S, Lombardi F, Augello FR, Barone A, Giannoni M, Cinque B, Pietropaoli D. Levilactobacillus brevis CD2 as a multifaceted probiotic to preserve oral health: results of a double-blind, randomized, placebo-controlled trial in healthy adults. J Transl Med. 2025 Jan 28;23(1):128. doi: 10.1186/s12967-024-06000-1.
PubMed 39875908
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effect of Levilactobacillus Brevis (CNCM I-5566) Probiotic Supplement on Clinical and Salivary Oral Indicators
- ClinicalTrials.gov ID
- NCT06457724
- Acronym / sponsor ID
- LBOH-RCT / 48/2022
- Conditions
- Oral Health, Oral Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 13 Jun 2024 (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.
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. The primary objective is to assess changes in salivary biomarkers, including salivary pH and buffer capacity; microbial composition using microbiome next-generation sequencing (NGS); and clinical oral inflammatory markers, such as full mouth bleeding score and full mouth plaque score, over a 4-week period. By comparing these indicators between the two groups, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases.
Detailed description
This RCT is designed to investigate the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. The study aims to provide robust evidence on the efficacy of this probiotic in promoting oral health and potentially preventing oral diseases.
Study Design:
Participants will be randomly assigned to one of two groups: the experimental group, which will receive the Levilactobacillus brevis CNCM I-5566 probiotic supplement, and the control group, which will receive a placebo. This random assignment ensures that the groups are comparable at the start of the trial, allowing for unbiased comparison of outcomes.
Duration:
The study will be conducted over a 4-week treatment period, during which participants will adhere to their assigned supplement regimen.
Primary Objectives:
The primary objective of this RCT is to assess the impact of Levilactobacillus brevis CNCM I-5566 on several key indicators of oral health, measured through salivary biomarkers, microbial composition, and clinical oral inflammatory markers.
Salivary Biomarkers:
Salivary pH: The acidity or alkalinity of saliva, which can influence oral health by affecting the growth of bacteria and the integrity of tooth enamel.
Buffer Capacity: The ability of saliva to neutralize acids, which is crucial for maintaining a healthy oral environment and preventing dental caries.
Salivation rate: The amount of salivary production (mL) overtime (in 5 minutes). This parameter is needed for individual caries risk assessment.
Microbial Composition:
The composition of the oral microbiome will be analyzed using next-generation sequencing (NGS). This advanced technique allows for a comprehensive assessment of the microbial populations present in the saliva and dental plaque, providing insights into how the probiotic supplement may alter the microbiome to support oral health.
Clinical Oral Inflammatory Markers:
Full Mouth Bleeding Score: A measure of gum inflammation and bleeding, which are indicators of gingivitis or periodontal disease.
Full Mouth Plaque Score: A measure of the accumulation of dental plaque, which is a biofilm of bacteria that can lead to tooth decay and gum disease if not properly managed.
Outcome Comparison:
By comparing the changes in these indicators between the probiotic supplement group and the placebo group, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566. Significant improvements in the probiotic group compared to the placebo group would suggest that Levilactobacillus brevis CNCM I-5566 is effective in promoting oral health and preventing oral diseases.
Significance:
This study has the potential to contribute valuable information to the field of oral health, particularly in understanding how probiotics can be used as a preventive measure against oral diseases. If successful, the findings could lead to new recommendations for probiotic use in dental care routines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. brevis | Experimental | Dietary Supplement: Levilactobacillus brevis CNCM I-5566 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers of both sexes.
- Dental caries experience (DMFT) less than 4.
Key exclusion criteria (9 listed)
- Active or historical periodontitis.
- Diabetes mellitus diagnosis.
- Active or historical cancer diagnosis.
- Antibiotic therapy within the past 3 months.
- Currently undergoing active therapy with drugs.
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 |
|---|---|---|
| Levilactobacillus brevis CNCM I-5566Also: MucomixxParticipants will take four Mucomixx tablets (containing Levilactobacillus brevis CNCM I-5566) daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner. | Dietary supplement | L. brevis |
| PlaceboParticipants will take four placebo tablets daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner. | Dietary supplement | Placebo |
Primary outcome
Salivary pH
Time frame: Baseline, 4 and 6 weeks
Assay used to define dental caries risk
Full mouth bleeding score
Time frame: Baseline, 4 and 6 weeks
Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)
Full mouth plauqe score
Time frame: Baseline, 4 and 6 weeks
Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)
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 5 Jul 2024.
- Derived from this study: PubMed 39875908Altamura S, Lombardi F, Augello FR, Barone A, Giannoni M, Cinque B, Pietropaoli D. Levilactobacillus brevis CD2 as a multifaceted probiotic to preserve oral health: results of a double-blind, randomized, placebo-controlled trial in healthy adults. J Transl Med. 2025 Jan 28;23(1):128. doi: 10.1186/s12967-024-06000-1.
- Individual participant dataSharing planned: No
Related trials for Oral Health
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Not yet recruiting
MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation
Gingival Hyperpigmentation, Oral Health-Related Quality of Life
Not yet recruiting
Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh
Pregnancy, Periodontal Diseases
Not yet recruitingObservational study
Womens Health Screening and the Oral Microbiome
Oral Health, Menopause
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 Levilactobacillus brevis CNCM I-5566 in people with Oral Health and Oral Disease, run by University of L'Aquila at 1 site in Italy.
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 2 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 5 Jul 2024. 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 Italy. 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?
Salivary pH (time frame: Baseline, 4 and 6 weeks). The study lists 3 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 NCT06457724, which also lists 1 linked publication.
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 5 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.