A randomized controlled trial: Photodynamic Treatment for the therapy of premalignant mucosal oral lesions. - PDT

Conditions: eukoplakia and oral lichen ruber.
MedDRA version: 12.1Level: LLTClassification code 10062037Term: Leukoplakia
MedDRA version: 12.1Level: PTClassification code 10062037Term: Leukoplakia
MedDRA version: 12.1Level: LLTClassification code 10030983Term: Oral lichen planus

Registration Number: EUCTR2010-018399-25-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik für Zahn-,Mund-u.Kieferheilkunde,Klin.Abt.f.orale Chirurg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
- Oral Lichen planus SIN III (diagnostics by Biopsie)
- Good mouth hygiene status (tartar, surface)
- Correct seat of the prosthesis and/or the denture
- Located erosions in the oral cavity
- Minimum age:18 years
- Women at the age capable of child-bearing with an appropriate contraception (at least 4 weeks before beginning of the study).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
- Pregnancy
- less than 18
- Satisfying women
- No tobacco abuse
- satisfying therapy with local immunmodulators in lichen ruber
- surgical therapy of leukoplakia indicated

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Establishment of standard minutes for the treatment of precancer-lesionen, therapy alternatives to the surgical Excision of mouth mucous membrane changes and secondary prevention of an oral disk epithelium carcinoma.;Secondary Objective: Mucosal changes over time;Primary end point(s): Size (in %) of the mouth mucous membrane change<br>

Secondary Outcome Measures