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NCT Number: NCT06234839

Lactobacillus Reuteri Strains for Gingivitis Reduction

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).

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Key information

Conditions

Gingival Inflammation Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Universidad Autónoma de san Luis Potosi

San Luis Potosí City, 78990, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Conventional mechanical periodontal therapy and oral anti-plaque hygiene training

Primary outcomes

  1. Gingival index

    Time frame: 0, 7, 14, 21 and 30 days.

    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.

  2. Plaque index

    Time frame: 0, 7, 14, 21 and 30 days.

    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.

  3. Bleeding on probing

    Time frame: 0, 7, 14, 21 and 30 days.

    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.

  4. Crevicular fluid volume

    Time frame: 0, 7, 14, 21 and 30 days.

    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.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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