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Prevention of Bone Necrosis induced by Radiotherapy in the oral cavity region with the drug combination of Pentoxifylline and Tocopherol: randomized clinical trial

Prevention of Osteoradionecrosis of the jaw with the drug combination of Pentoxifylline and Tocopherol: randomized clinical trial - PENTO Pentoxifylline and tocopherol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6tnqpjm
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-06-15
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Osteoradionecrosis

Interventions

This is a randomized clinical trial where patients will be recruited from the Dentistry outpatient clinic of the Pernambuco Cancer Hospital. The sample will consist of 40 patients, treated for maligna
E06.892
D03.633.100.759.758.824.651.700
D03.383.663.283.909.750

Sponsors

Sociedade Pernambucana de Combate ao Câncer
Lead Sponsor
Sociedade Pernambucana de Combate ao Câncer
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Older than 18 years; both genders; presence of teeth requiring extraction; history of radiotherapy to the head and neck with at least 40Gy to the maxilla and/or jaw; more than 3 months after the end of head and neck radiotherapy

Exclusion criteria

Exclusion criteria: Patients known to be allergic to pentoxifylline or tocopherol; individuals with systemic impairment that contraindicate the surgical procedure; patients undergoing palliative treatment, with no indication for surgical intervention

Design outcomes

Primary

MeasureTime frame
The drug combination of pentoxifylline and tocopherol is expected to have a prophylactic effect on the development of osteoradionecrosis of the jaw in patients undergoing tooth extraction.—

Secondary

MeasureTime frame
No secondary outcomes are expected.—

Countries

Brazil

Contacts

Public ContactRenata Arcoverde

Sociedade Pernambucana de Combate ao Câncer

renata.r.arcoverde@gmail.com+55(81)3217-8005

Outcome results

None listed

Source: REBEC (via WHO ICTRP)