Clinical trial NCT06234839: Lactobacillus Reuteri Strains for Gingivitis Reduction
Official title: Efficacy of Two Orally Administered Lactobacillus Reuteri Strains for Gingivitis Reduction in Young Adults: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Inflammation
Keywords: Gingivitis
Lactobacillus reuteri
Bacteriotherapy
Clinical randomized trial
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Non-smokers (at least for the last 6 months).
* Initial mean gingival index (GI) between 1.5 - 2.
* With a minimum of 20 teeth present in the oral cavity.

Exclusion Criteria:

* Periodontal pockets \> 4 mm.
* Recent intake of antibiotics or anti-inflammatory drugs and/or reception of dental prophylaxis.
* Daily consumption of analgesics, probiotics, or oral antimicrobial rinses/gels.
* Overweight (MCI \>25).
* Alcohol or recreative drug frequent consumers.
* Pregnancy or breast-feeding.
* Allergy or hypersensitivity to study products
* Fixed orthodontic appliances.

Primary outcomes:
measure: Gingival index
timeFrame: 0, 7, 14, 21 and 30 days.
measure: Plaque index
timeFrame: 0, 7, 14, 21 and 30 days.
measure: Bleeding on probing
timeFrame: 0, 7, 14, 21 and 30 days.
measure: Crevicular fluid volume
timeFrame: 0, 7, 14, 21 and 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
Study officials:
References: