Subjects
caries lesions, allergy, allergies
ALLERGY, PERIODONTAL DISEASE, ALLERGIES, FOOD ALLERGIES, PATHOLOGY
We invited 60 eligible patients (14–18 years) at the Orthodontic Specialist Clinic in Karlshamn, Sweden to enter the study. The subjects were consecutively enrolled and the inclusion criteria were: 1. being under treatment with fixed orthodontic appliances (uni- or bi-maxillary) for at least 3–6 months and 2. visible biofilm accumulation around the bracket bases of at least six teeth. Patients with caries lesions, periodontal disease, and/or soft tissue pathology were not invited. Likewise, we excluded patients with known food allergies or a history of allergies to ingredients in the test product, including allergy against enzymes. In total, 35 patients accepted the invitation and obtained verbal and written information about the project. We collected a signed consent from each patient and the custodians. The subjects were randomly allocated to the test or placebo group after the baseline registrations by opening a computer-generated numbered envelope.