Impact of Oral Probiotics on Oral Homeostasis
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Probiotic tablet
Placebo tablet
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
- age > 18 yrs.
Exclusion Criteria:
- gingivitis
- periodontitis
- dental caries
- systemic disease
- current medication
- antibiotic treatment within the latest 3 months.
Sites / Locations
- University of Copenhagen, Dept. of Odontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo Comparator
Arm Description
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
Placebo tablets 2 times/day for 12 weeks
Outcomes
Primary Outcome Measures
Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12
Alpha-diversity measured by shannon index
Secondary Outcome Measures
Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12
Mean levels of NGAL (mg/mL) measured by ELISA
Change in Salivary levels of transferrin from baseline to week 12
Mean levels of transferrin (mg/mL) measured by ELISA
Full Information
NCT ID
NCT04071210
First Posted
August 19, 2019
Last Updated
October 8, 2021
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04071210
Brief Title
Impact of Oral Probiotics on Oral Homeostasis
Official Title
Impact of Oral Probiotics on Oral Homeostasis - a Randomized Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blind clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
PI are the only one aware of participant status.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo tablets 2 times/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic tablet
Intervention Description
Probiotic tablet twice a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablet
Intervention Description
Placebo tablet twice a day for 12 weeks
Primary Outcome Measure Information:
Title
Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12
Description
Alpha-diversity measured by shannon index
Time Frame
Baseline alpha-diversity vs. alpha-diversity at week 12
Secondary Outcome Measure Information:
Title
Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12
Description
Mean levels of NGAL (mg/mL) measured by ELISA
Time Frame
Baseline levels vs. leves at week 12.
Title
Change in Salivary levels of transferrin from baseline to week 12
Description
Mean levels of transferrin (mg/mL) measured by ELISA
Time Frame
Baseline levels vs. leves at week 12.
Other Pre-specified Outcome Measures:
Title
Change in plaque index (PI) from baseline to week 12
Description
Mean levels of PI (% of sites with positive recordings)
Time Frame
Baseline recordings vs. recordings at week 12.
Title
Change in gingival inflammation index (GI) from baseline to week 12
Description
Mean levels of GI (% of sites with positive recordings)
Time Frame
Baseline recordings vs. recordings at week 12.
Title
Change in bleeding index (BI) from baseline to week 12
Description
Mean levels of BI (% of sites with positive recordings)
Time Frame
Baseline recordings vs. recordings at week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age > 18 yrs.
Exclusion Criteria:
gingivitis
periodontitis
dental caries
systemic disease
current medication
antibiotic treatment within the latest 3 months.
Facility Information:
Facility Name
University of Copenhagen, Dept. of Odontology
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Oral Probiotics on Oral Homeostasis
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