Clinical research on photodynamic therapy of gingival hypertrophy in orthodontic patients

Not Applicable

Recruiting

Conditions: K06.1
Gingival enlargement

Registration Number: DRKS00006292

Lead Sponsor: ChariteCentrum 3 für Zahn-, Mund und KieferheilkundeAbteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 29

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary outcome should be a reduction of periodontal bacteria. <br>Therefore data will be gained through PCR befor, during and at the end of the study.