Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-01-07
2023-12-06
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Probiotic group
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.
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.
No probiotic group
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial mean gingival index (GI) between 1.5 - 2.
* With a minimum of 20 teeth present in the oral cavity.
Exclusion Criteria
* 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.
18 Years
35 Years
ALL
Yes
Sponsors
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Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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José Arturo Garrocho Rangel
Proffesor/Lecturer/Reasearcher
Locations
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Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
San Luis Potosí City, , Mexico
Countries
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Other Identifiers
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LLeuteri220124
Identifier Type: -
Identifier Source: org_study_id