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

NCT04598633 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-05-18

No results posted yet for this study

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 the 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 and prevent a dysbiosis of the oral microbiome.

Conditions

  • Gingivitis
  • Orthodontic Appliance Complication

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

Placebo-lozenges (BioGaia)

Placebo-lozenges (BioGaia) 2 times per day for 12 weeks

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg

    lead OTHER

Principal Investigators

  • Corinna Lesley Seidel, Dr. · Department of Orthodontics and Orofacial Orthopedics

  • Lina Gölz, Prof.Dr. · Department of Orthodontics and Orofacial Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04598633 on ClinicalTrials.gov