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Lactobacillus Reuteri Strains for Gingivitis Reduction

U

Universidad Autonoma de San Luis Potosí

Status

Completed

Conditions

Gingival Inflammation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06234839
LLeuteri220124

Details and patient eligibility

About

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).

Full 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).

Enrollment

60 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Probiotic group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: L. reuteri (DSM 17938 and ATCC PTA 5289) in form of oral tablets
No probiotic group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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