Advances in the management of mandibular osteoradionecrosis: Pentoxyfilline and Tocopherol as medical treatment.
Phase 1
- Conditions
- Assess whether there is a clinically significant reduction in intraoral bone exposure (measured in mm) in the experimental group after the start of treatment with pentoxifylline and tocopherol (PENTO) for a minimum of 6months and a maximum of 18 months compared to the control group that will continue to make the standard treatment currently being undertaken in the service of CMF's Vall d'Hebron Hospital.Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2014-004975-22-ES
- Lead Sponsor
- Oral and Maxillofacial Surgery Department of Vall d'Hebron Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
symptoms of mandibular osteoradionecrosis in patients irradiated for head and neck cancer
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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
Exclusion Criteria
patients who are at a stage III in the classification of the mandibular osteoradionecrosis and require reconstructive surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Healing of mandibular osteoradionecrosis in patients irradiated for head and neck cance after treatment with Pentoxifilina and Tocopherol (PENTO);Secondary Objective: Subjective analysis by SOMA scale (Subjective Objective Management and Analytic evaluation of injury).<br>Differences in the clinical stage of ORN according to the WHO classification (2009) after treatment with PENTO.;Primary end point(s): Decreased intraoral bone exposure (mm);Timepoint(s) of evaluation of this end point: It will be assessed during clinic visits at this months: M0, M1, M3, M6, M9, M12, M18.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Subjective analysis by SOMA scale (Subjective Objective Management and Analytic evaluation of injury).<br>Improvement in the clinical stage of ORN according to the WHO classification (2009) after treatment with PENTO.;Timepoint(s) of evaluation of this end point: It will be assessed during clinic visits at this months: M0, M1, M3, M6, M9, M12, M18.