The effect of a plaque-identifying toothpaste on the amount of plaque in 12-16-year-old patients treated with fixed orthodontic appliances: a randomized, double-blind, controlled clinical trial
Prevention of plaque accumulation around brackets in patients with a malocclusion undergoing orthodontic fixed appliance treatment.
A prospective, randomised, double-blind, placebo-controlled trial will be conducted at the orthodontic department of the University Medical Center Groningen, the Netherlands. The G*Power program (G*Power, 3.1, Heinrich Heine Universität Düsseldorf, Dusseldorf, Germany) was used to determine the sample size of at least 66 patients and accounting for dropouts it was decided to include a total of at least 80 patients. Block randomization based on manual or electric toothbrush usage will be used, each block consisting of 6 participants (3 intervention, 3 placebo), all blinded and randomized. The two-arm intervention design will consist of a 6-week self-administration of a plaque identifying toothpaste (intervention) or a color-matched toothpaste (placebo) at least twice a day. Before the start of the study, opaque tubes (75ml) were randomly two-digit number-coded by an independent researcher not related to the trial according to the block randomization scheme and filled with the intervention or placebo toothpaste. After informed consent, patients (age 12-16) treated with fixed orthodontic appliances for at least three months will be recruited. At baseline (T0), Quantitative Light Fluorenes (QLF) pictures, demographic data, brushing type (electric or manual), additional oral care, Decayed, Missing, and Filled Permanent Teeth (DMFT), intra-oral light photographs (complementary to the QLF image) will be recorded. After 6 weeks at the end of the study (Tl), QLF pictures, intra-oral light photographs, therapy compliance and a user experience questionnaire will be recorded.
1. Patients who are treated in the Orthodontics department of the University Medical Center Groningen (UMCG) 2. Age category from 12 to 16 years 3. Under treatment with fixed orthodontic appliances in both jaws for at least three months 4. Twelve permanent anterior elements, namely from cuspid to cuspid, present 5. No syndromic or other craniofacial anomalies
1. Participants from the same family 2. Allergy to one of the components of the toothpastes used 3. Intervention or appointment with a dental professional (prevention assistant, dental hygienist, dentist or specialist) during the study