Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gingivitis
- Orthodontic Appliance Complication
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Monocentric, randomized, double-blind, placebo-controlled, clinical studyMasking: Double (Participant, Investigator)Masking Description: Study participants, meeting the inclusion criteria and not fulfilling the exclusion criteria, will be assigned to the study group or to the control group using a randomization plan. Randomization plan will be generated by the Center for Clincal Studies of the University Hospital of Erlangen. The lab manager will prepare storage boxes, in which exactly 168 lozenges will be stored. Half of the boxes will contain test-lozenges (study group), half or them will contain placebo-lozenges (control group). The storage boxes for the test and the placebo group will be identical and blinded. The storage boxes will be labelled with pseudonyms in accordance to the randomization plan generated by the Center for Clinical Studies. Therefore, study participants will not have knowledge of the group affiliation. The collection of the samples and the measuring of the clinical parameters will be performed by one orthodontist, who will be blinded to the randomization of the study participants.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 12 years and 17 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04598633
- Collaborators
- BioGaia AB
- Investigators
- Study Director: Corinna Lesley Seidel, Dr. Department of Orthodontics and Orofacial Orthopedics Study Director: Lina Gölz, Prof.Dr. Department of Orthodontics and Orofacial Orthopedics
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