K02.0 K05.0 K05.1
Conditions
Interventions
Group 1: 1. Appointment :
screening
determination of indexes: degree of accumulated plaque and bleedings
decision on whether to include the patient into the study depending on the PI- values
decision
the patient will be asked to familiarize with the product until the next appointment in 12 ± 2 days
In order to achieve an equal allocation of test participants, the probands will be allocated to the
Sponsors
OÄ der Abteilung für Zahnerhaltung und Präventive Zahnmedizin
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Inclusion criteria
Inclusion criteria: patients with fixed orthodontic appliances age: 12- 30 years, teeth of permanent dentition declaration of consent (parents and proband) only patients with metallic elements in their orthodontic appliance plaque index at first appointment: =1
Exclusion criteria
Exclusion criteria: generalized disease physical and mental handicap, which restricts physical and cognitive skills allergic reaction to substances used in the test process (e.g. abrasive polishing paste) missing declaration of consent gingival hyperplasia poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two indices will be used to measure the plaque accumulation (modified plaque index according to Silness & Loe) as well as the intensity and extent of oral bleedings ( papillary bleeding index) at the different regions ( interdental, around the orthodontic appliances, marginal) with a blunt probe. number of measurements: a total of 4 measurements: 1. Appointment : screening determination of indexes: degree of accumulated plaque and bleedings decision on whether to include the patient into the study depending on the PI- values decision which group to allocate the patient to, either A (AirFloss) or B (I-Prox) instructions on how to use the test products, hand out of AirFloss or I- Prox P brush for the patient to take home; the patient will be asked to familiarize with the product until the next appointment in 12± 2 days In order to achieve an equal allocation of test participants, the probands will be allocated to the two test groups. 2. Appointment : Tooth Cleaning after 12± 2 days Group A and Group B determination of indexes tooth cleaning through the test administration to establish a standardized and equal status of oral hygiene before starting the 48h plaque growth phase The next appointment will be set up 48h later. In the meantime, the patient will be asked to neither brush the teeth nor use the AirFloss or I-Prox brush. This is necessary to ensure a standardized and approximately equal amount of plaque across participants. 3. Appointment : Single-use Group A and Group B determination of indexes The patient will be asked to clean all teeth with brackets and bands (either with the AirFloss or the brush) for four minutes and to switch the quadrant in a clockwise direction after one minute. repeated determination of indexes Long-term Observation Six weeks after the third appointment the proband will be asked to come in for another appointment. During these six weeks the patient will be requested to brush his/ her teeth for four minutes every day with the | — |
Secondary
| Measure | Time frame |
|---|---|
| after the 4th appointment: The subjective experience of patients will be assessed through a questionnaire. Some examples: handling, reachability of difficult Areas and tooth Groups, cleaning efficiency | — |
Countries
Germany
Contacts
Public ContactCarolin;Charlotte Paulina- Marie Winkler;Sonnenschein
Universität Witten/ Herdecke;Universität Witten/Herdecke
Outcome results
None listed