Influence of Probiotics on Clinical Parameters the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    34
  • sponsor
    University of Erlangen-Nürnberg
Updated on 26 January 2021
Investigator
Corinna Lesley Seidel, Dr.
Primary Contact
Department of Orthodontics and Orofacial Orthopedics (8.7 mi away) Contact

Summary

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus.

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.

Details
Condition Gingivitis, Orthodontic Appliance Complication, Periodontal Inflammation
Treatment Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289), Placebo-lozenges (BioGaia)
Clinical Study IdentifierNCT04606186
SponsorUniversity of Erlangen-Nürnberg
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults (18 years and older) with fixed appliances undergoing orthodontic treatment
Signed declaration of consent by the patient

Exclusion Criteria

Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome
obesity
body mass index (BMI) > 30 kg/m (weight and height will be measured)
Eating disorder or underweight
BMI < 18,5 kg/m (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
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