Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04598633
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT04598633
Study Brief:
Protocol Section:
NCT04598633