Impact of Oral Probiotics on Oral Homeostasis

NCT04071210 | Completed DMC

• 1 other identifier: UCPH_OI_003
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in salivary levels of neutrophil gelatinase-associated lipocalin (NGAL) from baseline to week 12

  Baseline levels vs. leves at week 12.

• Change in Salivary levels of transferrin from baseline to week 12

  Baseline levels vs. leves at week 12.

Other Outcomes (3)

• Change in plaque index (PI) from baseline to week 12

  Baseline recordings vs. recordings at week 12.

• Change in gingival inflammation index (GI) from baseline to week 12

  Baseline recordings vs. recordings at week 12.

• Change in bleeding index (BI) from baseline to week 12

  Baseline recordings vs. recordings at week 12.

Study Arms (2)

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

Dietary Supplement: Probiotic tablet

Placebo Comparator

PLACEBO COMPARATOR

Placebo tablets 2 times/day for 12 weeks

Dietary Supplement: Placebo tablet

Interventions

Probiotic tablet DIETARY_SUPPLEMENT

Probiotic tablet twice a day for 12 weeks

Experimental

Placebo tablet DIETARY_SUPPLEMENT

Placebo tablet twice a day for 12 weeks

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 18 yrs.

You may not qualify if:

• gingivitis
• periodontitis
• dental caries
• systemic disease
• current medication
• antibiotic treatment within the latest 3 months.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen, Dept. of Odontology

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI are the only one aware of participant status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Principal Investiator, dr. odont., PhD, DDS

Model Details: Randomized double blind clinical trial

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)