K06.1
Conditions
Interventions
Group 1: Arm 1: Test side
29 patients, who suffer from gingival hypertrophy due to orthodontic appliances (bands, braces) are going to be treated with the Photodynamic Therapy. After a professional to
Sponsors
ChariteCentrum 3 für Zahn-, Mund und KieferheilkundeAbteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: Every patient, who suffers from gingival hypertrophy at least on the 1st molars and 2nd incisors, due to orthodontic appliances (bands, braces) is able to participate in our clinical trial. It's necessary that the orthodontic treatment holds up for at least 9 more weeks. Compliance and reliability are preconditions. Patients, who are under age, need an agreement from their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Patient and/or legal guardian does not want to participate the clinical trial 2. Patient is not peridontal healthy when he starts orthodontic treatment (peridontal screening index is bigger than 1) 3. Orthodontic treatment does not hold up 9 more weeks 4. General diseases for example leukemia, hereditary gingival fibromatosis etc. and physically or mentally disabled persons 5. Pregnant women 6. Antibiosis in the last 4 weeks before or during the study 7. Medication with drugs, which may induce gingival hypertrophy 8. Antibacterial or antiseptic mouth wash or ointment frequently used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome should be a reduction of the gingival hypertrophy and the gingival bleeding. Therefore data will be gained through parameters (measuring the distance between the highest point of the gingival enlargement and a certain point on the orthodontic appliance and evaluating the modified papillary bleeding index) before, during and at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome should be a reduction of periodontal bacteria. Therefore data will be gained through PCR befor, during and at the end of the study. | — |
Countries
Germany
Contacts
Public ContactRana Manjah
Charite Centrum 3 für Zahn-, Mund- und Kieferheilkunde
Outcome results
None listed