NCT06234839

Lactobacillus Reuteri Strains for Gingivitis Reduction

Efficacy of Two Orally Administered Lactobacillus Reuteri Strains for Gingivitis Reduction in Young Adults: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidad Autonoma de San Luis Potosí · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study was to investigate the potential beneficial effects in volunteer young adults of orally administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).

Detailed description

Aim. To investigate the potential beneficial effects in volunteer young adults of orally daily administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration). Methods. A randomized controlled parallel clinical trial was conducted in sixty young adults (18-35 yrs old) with chronic marginal gingivitis for one month. Initially, both study groups underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. However, the experimental group additionally received the administration of two daily tablets, containing both L. reuteri strains, for 30 days, while the control group did not. Different clinical outcome variables (plaque (PI) and gingival (GI) indices, bleeding on probing (BOP), and crevicular fluid volume (CFV)) were recorded and compared between the study groups, both at baseline and at the end of the interventions, 30 days later. Statistical descriptive and inferential tests were performed (data distribution normality, Student's t, and Wilcoxon-Mann-Whitney tests).

Conditions

• Gingival Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri (DSM 17938 and ATCC PTA 5289) in form of oral tablets	Each subject of the experimental group was instructed to dissolve inside the mouth two tablets per day (in the morning and before going to bed at night), during the experimental period of 30 days. The tablets were provided by BioGaia ProDentis® (Stockholm, Sweden). The tablets contained two strains of L. reuteri (DSM-17938 and ATCC PTA 5289), at a dose of 2 x 108 CFU/tablet.

Timeline

• Start date: 2023-01-07
• Primary completion: 2023-07-18
• Completion: 2023-12-06
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: Mexico