Lactobacillus Reuteri Strains for Gingivitis Reduction

Gingival Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06234839
• Other study ID #: LLeuteri220124
• Status: Completed
• Phase: N/A
• Start date: January 7, 2023
• Est. completion date: December 6, 2023

Study information

• Verified date: January 2024
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 6, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Inflammation
• Gingivitis
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
Mexico	Faculty of Dentistry, Universidad Autónoma de san Luis Potosi	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival index	The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3, being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.	0, 7, 14, 21 and 30 days.
Primary	Plaque index	The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The bacterial plaque developer solution was used to define cumulative amounts of plaque with criteria from 0 to 5.	0, 7, 14, 21 and 30 days.
Primary	Bleeding on probing	BOP describes bleeding induced by gentle manipulation of the tissue. The probing is typically completed to the depth of the gingival sulcus, or the area between the gingiva and the tooth.	0, 7, 14, 21 and 30 days.
Primary	Crevicular fluid volume	Gingival crevicular fluid is an inflammatory exudate derived from the periodontal tissues. It is composed of serum and locally generated materials such as tissue breakdown products, inflammatory mediators, and antibodies directed against dental plaque bacteria.	0, 7, 14, 21 and 30 days.