Fixed orthodontic appliances are used in children and adolescents to correct dental and jaw misalignments. After placement of the fixed appliance, maintaining oral hygiene can become more difficult, leading to the accumulation of dental plaque. This may result in gum inflammation (gingivitis), enamel demineralization (white spots), and changes in the oral microbiome.
Conditions
Interventions
Group 1: Adolescents (age 12–17) undergoing treatment with fixed orthodontic appliances. Twice-daily (1-0-1) intake of probiotic lozenges (Limosilactobacillus reuteri) during the first three months af
Sponsors
Uniklinik Erlangen Zahnklinik 3 - Kieferorthopädie
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Adolescents (age 12 – 17) undergoing orthodontic treatment with fixed appliance 2. Signed informed consent und declaration of consent by the patients and their parents/legal guardians
Exclusion criteria
Exclusion criteria: 1. Patients with active periodontal disease 2. Patients who have undergone periodontal therapy within the last six months before insertion of fixed appliance 3. Systemic or metabolic diseases that can be associated with or influence gingivitis (e.g., diabetes mellitus, active juvenile rheumatoid arthritis, leukemia, cancer) or that can affect the composition of the oral microbiome (e.g., chemotherapy, radiation therapy) 4. Use of anti-inflammatory medications (e.g., NSAIDs) 5. Obesity: Adolescents with a BMI > +2 standard deviations (SD) above the average value according to World Health Organization (WHO) for adolescents 6. Eating disorders or underweight adolescents: BMI > -2 SD under the average value according to WHO for adolescents 7. Above-average consumption of milk products defined as > 3 portions/day: > 1.2 L of milk or 1200 g of yoghurt/day (recommended daily intake by the German Nutrition Society: 1-3 portions of milk products corresponding to 250-310 g/day) 8. Allergy to ingredients of the lozenges 9. Use of antibiotics or probiotics within the last 6 months or during the study 10. regular use of antibacterial mouth wash 11. Pregnancy 12. Smoking 13. Withdrawal of the declaration of consent by the patients or their parents/legal guardians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingiva Index (according to Silness & Löe): Effect of probiotic intake compared to control lozenge intake T0: Before placement of the fixed orthodontic appliance T1: One week after placement T2: Four weeks after placement T3: Twelve weeks after placement (last day of lozenge intake) T4: Six months after placement | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in clinical parameters: periodontal probing depth (PPD), Modified Plaque Index (MPI according to Attin) Investigation of the impact on the oral microbiome and local cytokine concentration in oral niches: sulcus fluid, supragingival plaque, saliva, tongue, hard palate, cheek, and sublingual region. Influence of diet (dietary journal) Influence of oral hygiene (questionnaire) | — |
Countries
Germany
Outcome results
None listed