Lactobacillus Brevis Oral Health

Oral Health Clinical Trial

— LBOH-RCT  

Official title:

Randomized Controlled Trial on the Effect of Lactobacillus Brevis CD2 Probiotic Supplement on Salivary and Oral Health Indicators

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06457724
• Other study ID #: 48/2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This RCT investigates the impact of an oral supplement containing the probiotic Lactobacillus brevis CD2 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 Lactobacillus brevis CD2 in promoting oral health and potentially preventing oral diseases.

Description:

This RCT is designed to investigate the impact of an oral supplement containing the probiotic Lactobacillus brevis CD2 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 Lactobacillus brevis CD2 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 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 Lactobacillus brevis CD2 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.

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, 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 Lactobacillus brevis CD2. Significant improvements in the probiotic group compared to the placebo group would suggest that Lactobacillus brevis CD2 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers of both sexes.

• Dental caries experience (DMFT) less than 4.

Exclusion Criteria:

• 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.

• Recent professional oral hygiene treatment within the last 3 months.

• Pregnancy.

• Presence of eating disorders.

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Disease
• Oral Health

Intervention

Dietary Supplement:
• L. Brevis CD2 DSM 27961
Participants will take four Mucomixx tablets (containing Lactobacillus brevis DSM 27961) daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner.
• Placebo
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.

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'Aquila	IT

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary pH	Assay used to define dental caries risk	Baseline, 4 and 6 weeks
Primary	Full mouth bleeding score	Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)	Baseline, 4 and 6 weeks
Primary	Full mouth plauqe score	Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)	Baseline, 4 and 6 weeks