Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457724
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-07
Brief Title:
Levilactobacillus Brevis Oral Health
Sponsor:
University of LAquila
Organization:
University of LAquila
Study Overview
Official Title:
Randomized Controlled Trial on the Effect of Levilactobacillus Brevis CNCM I-5566 Probiotic Supplement on Clinical and Salivary Oral Indicators
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LBOH-RCT
Brief Summary:
This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 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 Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases
Detailed Description:
This RCT is designed to investigate the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 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 Levilactobacillus brevis CNCM I-5566 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 treatment 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 Levilactobacillus brevis CNCM I-5566 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
Salivation rate The amount of salivary production mL overtime in 5 minutes This parameter is needed for individual caries risk assessment
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 and dental plaque 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 Levilactobacillus brevis CNCM I-5566 Significant improvements in the probiotic group compared to the placebo group would suggest that Levilactobacillus brevis CNCM I-5566 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
Study Design
Participants will be randomly assigned to one of two groups the experimental group which will receive the Levilactobacillus brevis CNCM I-5566 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 treatment 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 Levilactobacillus brevis CNCM I-5566 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
Salivation rate The amount of salivary production mL overtime in 5 minutes This parameter is needed for individual caries risk assessment
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 and dental plaque 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 Levilactobacillus brevis CNCM I-5566 Significant improvements in the probiotic group compared to the placebo group would suggest that Levilactobacillus brevis CNCM I-5566 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None