GingivitisNCT04071210
Impact of Oral Probiotics on Oral Homeostasis
A study testing Probiotic tablet in people with Gingivitis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Aim: To evaluate the effect of three months use of tablets containing probiotics on the composition of the supragingival plaque microbiota and salivary levels of inflammation-related proteins in oral healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Probiotic tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 10 Mar 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age > 18 yrs.
Who cannot join
- gingivitis
- periodontitis
- dental caries
- systemic disease
- current medication
- antibiotic treatment within the latest 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oral Probiotics on Oral Homeostasis - a Randomized Double Blind Study
Aim:
To evaluate the effect of three months use of tablets containing probiotics on the composition of the supragingival plaque microbiota and salivary levels of inflammation-related proteins in oral healthy individuals.
Read more
Hypothesis:
Three months use of tablets containing probiotics will induce quantifiable changes to the composition of the supragingival plaque microbiota and salivary levels of inflammation-related proteins in oral healthy individuals.
Perspectives:
Data from the present study will be able to reveal the impact of regular use of probiotics on oral homeostasis in oral healthy individuals. Specifically, simultaneous registration of clinical, microbial and inflammatory characteristics will provide comprehensive information on the potential beneficial effect of regular use of oral probiotics on maintenance of oral homeostasis. Thus, data from the present study will provide a scientific platform, which dentist and dental hygienist can utilize when deciding if oral healthy individuals may benefit from using oral probiotics as a supplement to regular oral hygiene.
Read the detailed description
Oral health is built upon a symbiotic relationship between the resident oral microbiota and the immune system of the host. Therefore, structural or functional changes to either the microbiota or the immune system may result in dysbiosis, which in turn can lead to oral diseases such as gingivitis, periodontitis and dental caries.
The composition of the resident oral microbiota in oral health is shaped by ecological properties found at various sites of the oral cavity, which is why major site-specific variations are observed. Interestingly, the composition of the oral microbiota is individualized and relatively time stable as long as oral homeostasis is maintained. However, structure and function of the oral microbiota can be altered by internal and external perturbations. For example, it has previously demonstrated that oral hygiene discontinuation induces structural changes to the supragingival plaque microbiota, whereas non-surgical periodontal treatment has deep impact on the composition of the subgingival plaque microbiota. Interestingly, a recent study demonstrated that the composition of the resident oral microbiota may also be influenced by external perturbations. Specifically, daily use of ZendiumTM toothpaste for 12 weeks was reported to induce significant changes to the supragingival plaque microbiota in oral healthy individuals with an increase in health-associated bacterial species.
Probiotics is the term used when a harmless effector strain is implanted in the host's microbiota to maintain or restore a natural microbiome by interference and/or inhibition of other microorganisms, and especially pathogens. In a recent study, it was demonstrated an effect of using tablets containing a mix of Lactobacillus rhamnosus PB01, DSM 14869 and Lactobacillus curvatus EB10, DSM 32307 on gingival inflammation. Specifically, daily use of this probiotic candidate for four weeks resulted in significant reduction in clinical parameters such as bleeding on probing (BOP) and amount of gingival crevicular fluid (GCF).
However, at present it is not known if daily use of a probiotic tablet containing a mix of L. rhamnosus PB01, DSM 14869 and L. curvatus EB10, DSM 32307 is able to induce shifts to the composition of the oral microbiota, or cause a decrease in salivary levels of inflammation-related proteins such as neutrophil gelatinase-associated lipocalin (NGAL) and transferrin, which is the purpose of the present study.
- Conditions
- Gingivitis
- Being tested
- Probiotic tablet, Placebo tablet
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic tabletDietary supplement
Probiotic tablet twice a day for 12 weeks
Placebo tabletDietary supplement
Placebo tablet twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Probiotic tablets (containing a mix of Lactobacillus rhamnosus PB01, DSM 14869 and Lactobacillus curvatus EB10, DSM 32307, 1*10(9) CFU) 2 times/day for 12 weeks Receives: Dietary Supplement: Probiotic tablet |
| Placebo Comparator | Placebo comparator | Placebo tablets 2 times/day for 12 weeks Receives: Dietary Supplement: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12
Alpha-diversity measured by shannon index
Measured: Baseline alpha-diversity vs. alpha-diversity at week 12
Secondary outcomes (2)
Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12
Mean levels of NGAL (mg/mL) measured by ELISA
Measured: Baseline levels vs. leves at week 12.
Change in Salivary levels of transferrin from baseline to week 12
Mean levels of transferrin (mg/mL) measured by ELISA
Measured: Baseline levels vs. leves at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Model description
- Randomized double blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Belstrøm, DDS, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071210
- Sponsor's protocol ID
- UCPH_OI_003
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2019
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Probiotics on Oral Homeostasis - a Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04071210
- Acronym / sponsor ID
- UCPH_OI_003
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Aim:
To evaluate the effect of three months use of tablets containing probiotics on the composition of the supragingival plaque microbiota and salivary levels of inflammation-related proteins in oral healthy individuals.
Hypothesis:
Three months use of tablets containing probiotics will induce quantifiable changes to the composition of the supragingival plaque microbiota and salivary levels of inflammation-related proteins in oral healthy individuals.
Perspectives:
Data from the present study will be able to reveal the impact of regular use of probiotics on oral homeostasis in oral healthy individuals. Specifically, simultaneous registration of clinical, microbial and inflammatory characteristics will provide comprehensive information on the potential beneficial effect of regular use of oral probiotics on maintenance of oral homeostasis. Thus, data from the present study will provide a scientific platform, which dentist and dental hygienist can utilize when deciding if oral healthy individuals may benefit from using oral probiotics as a supplement to regular oral hygiene.
Detailed description
Oral health is built upon a symbiotic relationship between the resident oral microbiota and the immune system of the host. Therefore, structural or functional changes to either the microbiota or the immune system may result in dysbiosis, which in turn can lead to oral diseases such as gingivitis, periodontitis and dental caries.
The composition of the resident oral microbiota in oral health is shaped by ecological properties found at various sites of the oral cavity, which is why major site-specific variations are observed. Interestingly, the composition of the oral microbiota is individualized and relatively time stable as long as oral homeostasis is maintained. However, structure and function of the oral microbiota can be altered by internal and external perturbations. For example, it has previously demonstrated that oral hygiene discontinuation induces structural changes to the supragingival plaque microbiota, whereas non-surgical periodontal treatment has deep impact on the composition of the subgingival plaque microbiota. Interestingly, a recent study demonstrated that the composition of the resident oral microbiota may also be influenced by external perturbations. Specifically, daily use of ZendiumTM toothpaste for 12 weeks was reported to induce significant changes to the supragingival plaque microbiota in oral healthy individuals with an increase in health-associated bacterial species.
Probiotics is the term used when a harmless effector strain is implanted in the host's microbiota to maintain or restore a natural microbiome by interference and/or inhibition of other microorganisms, and especially pathogens. In a recent study, it was demonstrated an effect of using tablets containing a mix of Lactobacillus rhamnosus PB01, DSM 14869 and Lactobacillus curvatus EB10, DSM 32307 on gingival inflammation. Specifically, daily use of this probiotic candidate for four weeks resulted in significant reduction in clinical parameters such as bleeding on probing (BOP) and amount of gingival crevicular fluid (GCF).
However, at present it is not known if daily use of a probiotic tablet containing a mix of L. rhamnosus PB01, DSM 14869 and L. curvatus EB10, DSM 32307 is able to induce shifts to the composition of the oral microbiota, or cause a decrease in salivary levels of inflammation-related proteins such as neutrophil gelatinase-associated lipocalin (NGAL) and transferrin, which is the purpose of the present study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Probiotic tabletProbiotic tablets (containing a mix of Lactobacillus rhamnosus PB01, DSM 14869 and Lactobacillus curvatus EB10, DSM 32307, 1*10(9) CFU) 2 times/day for 12 weeks |
| Placebo Comparator | Placebo comparator | Dietary Supplement: Placebo tabletPlacebo tablets 2 times/day for 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age > 18 yrs.
Key exclusion criteria (6 listed)
- gingivitis
- periodontitis
- dental caries
- systemic disease
- current medication
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 |
|---|---|---|
| Probiotic tabletProbiotic tablet twice a day for 12 weeks | Dietary supplement | Experimental |
| Placebo tabletPlacebo tablet twice a day for 12 weeks | Dietary supplement | Placebo Comparator |
Primary outcome
Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12
Time frame: Baseline alpha-diversity vs. alpha-diversity at week 12
Alpha-diversity measured by shannon index
2 secondary outcomes
Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12
Time frame: Baseline levels vs. leves at week 12.
Change in Salivary levels of transferrin from baseline to week 12
Time frame: Baseline levels vs. leves at week 12.
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 11 Oct 2021.
- 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 Probiotic tablet in people with Gingivitis, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 6 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 11 Oct 2021. 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 Denmark. 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?
Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12 (time frame: Baseline alpha-diversity vs. alpha-diversity at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2021.