Impact of Oral Probiotics on Oral Homeostasis

Gingivitis Clinical Trial

Official title:

Impact of Oral Probiotics on Oral Homeostasis - a Randomized Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071210
• Other study ID #: UCPH_OI_003
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: October 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• age > 18 yrs.

Exclusion Criteria:

• gingivitis

• periodontitis

• dental caries

• systemic disease

• current medication

• antibiotic treatment within the latest 3 months.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Dietary Supplement:
• Probiotic tablet
Probiotic tablet twice a day for 12 weeks
• Placebo tablet
Placebo tablet twice a day for 12 weeks

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Dept. of Odontology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plaque index (PI) from baseline to week 12	Mean levels of PI (% of sites with positive recordings)	Baseline recordings vs. recordings at week 12.
Other	Change in gingival inflammation index (GI) from baseline to week 12	Mean levels of GI (% of sites with positive recordings)	Baseline recordings vs. recordings at week 12.
Other	Change in bleeding index (BI) from baseline to week 12	Mean levels of BI (% of sites with positive recordings)	Baseline recordings vs. recordings at week 12.
Primary	Change in bacterial diversity of supragingival plaque microbiota from baseline to week 12	Alpha-diversity measured by shannon index	Baseline alpha-diversity vs. alpha-diversity at week 12
Secondary	Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12	Mean levels of NGAL (mg/mL) measured by ELISA	Baseline levels vs. leves at week 12.
Secondary	Change in Salivary levels of transferrin from baseline to week 12	Mean levels of transferrin (mg/mL) measured by ELISA	Baseline levels vs. leves at week 12.