Advances in the management of mandibular osteoradionecrosis: Pentoxyfilline and Tocopherol as medical treatment.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004975-22-ES

Enrollment

Registered

2015-06-01

Start date

2015-09-03

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 6 months 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.

Interventions

Product Name: Pentoxifilina Pharmaceutical Form: Buccal tablet INN or Proposed INN: PENTOXIFYLLINE CAS Number: 6493-05-6 Current Sponsor code: ORN-2014-16 Other descriptive name: Pentoxifilina Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: patients who are at a stage III in the classification of the mandibular osteoradionecrosis and require reconstructive surgery.

Design outcomes

Primary

Measure	Time frame
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). 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.	—

Measure

Time frame

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). 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

Measure	Time frame
Secondary end point(s): Subjective analysis by SOMA scale (Subjective Objective Management and Analytic evaluation of injury). 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.	—

Countries

Spain

Contacts

Public ContactMaxillofacial Department

Oral and Maxillofacial Surgery Department of Vall d'Hebron Hospital

miryam-martos@hotmail.com34620684875

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026