Clinical trial NCT04598633: Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment
Official title: Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment: a Prospective, Double-blind, Randomized, Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingivitis
Orthodontic Appliance Complication
Keywords: Orthodontics; Inflammation; Microbiome; Probiotics
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2020-10-22
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, randomized, double-blind, placebo-controlled, clinical study
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Gingival Index (GI)
timeFrame: Baseline to week 4 of intake
Secondary outcomes:
measure: Probing pocket depth (PPD) (4-point-measurement)
timeFrame: Baseline till 12 months after insertion of appliance
measure: Modified Plaque Index (MPI)
timeFrame: Baseline till 12 months after insertion of appliance
measure: Local cytokine expression
timeFrame: Baseline till 12 months after insertion of appliance
measure: Oral microbiome
timeFrame: Baseline till 12 months after insertion of appliance
Other outcomes:
measure: Adverse events
timeFrame: Baseline till 12 months after insertion of appliance.
Locations:
city: Erlangen
country: Germany
facility: UniversityHospitalErlangen-Nurenberg
state: Bavaria
Study officials:
affiliation: Department of Orthodontics and Orofacial Orthopedics
name: Corinna Lesley Seidel, Dr.
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics and Orofacial Orthopedics
name: Lina Gölz, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: 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.