Lactobacillus Reuteri Strains for Gingivitis Reduction

NCT06234839 | Completed

• 1 other identifier: LLeuteri220124
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Gingival Inflammation

Keywords

Gingivitis; Lactobacillus reuteri; Bacteriotherapy; Clinical randomized trial

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Probiotic group

EXPERIMENTAL

The experimental group received conventional mechanical periodontal therapy and oral anti-plaque hygiene training, plus the administration of two daily tablets, containing both L. reuteri strains, for 30 days.

Dietary Supplement: L. reuteri (DSM 17938 and ATCC PTA 5289) in form of oral tablets

No probiotic group

NO INTERVENTION

The control group also received conventional mechanical periodontal therapy and oral anti-plaque hygiene training; however, this group did not receive the administration of the probiotic tablets.

Interventions

L. reuteri (DSM 17938 and ATCC PTA 5289) in form of oral tablets DIETARY_SUPPLEMENT

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.

Also known as: Conventional mechanical periodontal therapy and oral anti-plaque hygiene training

Probiotic group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Faculty of Dentistry, Universidad Autónoma de san Luis Potosi

San Luis Potosí City, 78990, Mexico

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical evaluators of the results were unaware that each patient belonged to one of the 2 study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor/Lecturer/Reasearcher

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: January 7, 2023
• Primary Completion: July 18, 2023
• Study Completion: December 6, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)