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

University of Erlangen-Nürnberg

Status: Unknown

Conditions: Orthodontic Appliance Complication; Gingivitis

Treatments: Dietary Supplement: Placebo-lozenges (BioGaia); Dietary Supplement: Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04598633

ER-Ortho-Pro-RCT-1

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adolescents from age 12 to 17 with fixed appliances undergoing orthodontic treatment
• Signed declaration of consent by the patient and the parent or legal guardian for adolescent patients

Exclusion criteria

• Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome

• obesity:

  -adolescents: body mass index > + 2 standard deviations (SD) over the average value given by the World Health Organisation (weight and height will be measured)

• Eating disorder or underweight

  -adolescents: BMI > -2 SD under the average value given by the WHO (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 and the parent or legal guardian for adolescent patients

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri Prodentis®-lozenges

Active Comparator group

Treatment:

Dietary Supplement: Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)

Placebo-lozenges (BioGaia)

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo-lozenges (BioGaia)