Prophylaxis with PENTO before tooth extraction

Prophylactic treatment of osteoradionecrosis (ORN) with pentoxifylline and a-tocopherol (PENTO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000887-32-SE

Enrollment

Registered

2015-05-11

Start date

2015-07-20

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Osteoradionecrosis MedDRA version: 18.0 Level: PT Classification code 10031264 Term: Osteonecrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0 Level: PT Classification code 10067352 Term: Osteoradionecrosis System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Trental Product Name: Trental (pentoxyfylline) Product Code: NDC: 0039-0078-10 Pharmaceutical Form: Tablet INN or Proposed INN: PENTOXIFYLLINE CAS Number: 6493-05-6 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Tissue-scale (SH) index S0H2-3 or S1H1-3 • Men and women aged =18 years • Understand the Swedish speaking and writing 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective is to evaluate tissue and bone healing in the short and long term;Secondary Objective: To evaluated the treatment effect on pain and infection, jaw opening capasity, saliva secretion, quality of life and the genotype and gene expression;Primary end point(s): Status evaluated according Tissue-scale,i.e. extent of bone lesion measured in mm. Primary endpoint is change in the SH index measured with clinical and radiological methods.;Timepoint(s) of evaluation of this end point: 3, 6 24 months	—

Measure

Time frame

Main Objective: Primary objective is to evaluate tissue and bone healing in the short and long term;Secondary Objective: To evaluated the treatment effect on pain and infection, jaw opening capasity, saliva secretion, quality of life and the genotype and gene expression;Primary end point(s): Status evaluated according Tissue-scale,i.e. extent of bone lesion measured in mm. Primary endpoint is change in the SH index measured with clinical and radiological methods.;Timepoint(s) of evaluation of this end point: 3, 6 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): •Pain intensity according to VAS scale procedures. •Infection measured on a three-point scale •Jaw opening measured in millimeters •Salivation measured as ml stimulated saliva /min •Quality of Life (QLQ C-30, QLQ H & N35) •Gene expression in the irradiated tissue and genetic profile;Timepoint(s) of evaluation of this end point: 3, 6 24 months	—

Countries

Sweden

Contacts

Public ContactKäkkirurgiska kliniken

Västra Götalandsregionen/NÄL

josephine.skoldestam@vgregion.se+46(0)70 289 59 59

Outcome results

None listed

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