Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients
NCT ID: NCT04606186
Last Updated: 2022-05-18
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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UNKNOWN
NA
34 participants
INTERVENTIONAL
2020-10-19
2023-11-01
Brief Summary
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Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment.
Therefore, the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation, systemic inflammation and prevent a dysbiosis of the oral microbiome.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lactobacillus reuteri Prodentis®-lozenges
Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)
Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks
Placebo-lozenges (BioGaia)
Placebo-lozenges (BioGaia)
Placebo-lozenges (BioGaia)
Interventions
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Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)
Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks
Placebo-lozenges (BioGaia)
Placebo-lozenges (BioGaia)
Eligibility Criteria
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Inclusion Criteria
* Signed declaration of consent by the patient
Exclusion Criteria
• obesity:
* body mass index (BMI) \> 30 kg/m² (weight and height will be measured)
• Eating disorder or underweight
* BMI \< 18,5 kg/m² (weight and height will be measured)
* Above-average consumption of milk products: \> 3 portions/day = \>1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products)
* allergy to ingredients of the lozenges
* intake of antibiotics or dietary supplementation (probiotics, vitamin C/D) in the last 6 months or during the study
* regular use of antibacterial mouth wash
* pregnancy
* smoking
* retraction of the declaration of consent by the patient
18 Years
ALL
Yes
Sponsors
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BioGaia AB
INDUSTRY
University of Erlangen-Nürnberg
OTHER
Responsible Party
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Dr. Corinna Lesley Seidel
Orthodontist
Principal Investigators
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Corinna Lesley Seidel, Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Orofacial Orthopedics
Lina Gölz, Prof.Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Orofacial Orthopedics
Locations
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Department of Orthodontics and Orofacial Orthopedics
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Seidel CL, Gerlach RG, Weider M, Wolfel T, Schwarz V, Strobel A, Schmetzer H, Bogdan C, Golz L. Influence of probiotics on the periodontium, the oral microbiota and the immune response during orthodontic treatment in adolescent and adult patients (ProMB Trial): study protocol for a prospective, double-blind, controlled, randomized clinical trial. BMC Oral Health. 2022 Apr 27;22(1):148. doi: 10.1186/s12903-022-02180-8.
Other Identifiers
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ER-Ortho-Pro-RCT-Erw-2
Identifier Type: -
Identifier Source: org_study_id
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