Lactobacillus Reuteri Strains for Gingivitis Reduction
Efficacy of Two Orally Administered Lactobacillus Reuteri Strains for Gingivitis Reduction in Young Adults: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
San Luis Potosi, Mexico, 78990
- Faculty of Dentistry, Universidad Autónoma de san Luis Potosi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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:
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0, 7, 14, 21 and 30 days.
|
|
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.
|
0, 7, 14, 21 and 30 days.
|
|
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.
|
0, 7, 14, 21 and 30 days.
|
|
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.
|
0, 7, 14, 21 and 30 days.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LLeuteri220124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.