Use of Pentoxifylline and Tocopherol before Tooth Extractions in Cancer patients undergoing treatment with bone Medications

Use of Pentoxyphylline and Tocopherol prior to Tooth Extractions in Oncological patients submitted to treatment with Agents Bone Modifiers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-52ynn6j

Enrollment

Unknown

Registered

2022-06-23

Start date

2021-04-04

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

Osteonecrosis

Interventions

This is a non-randomized, phase II clinical trial using the drug off-label. The interventions performed were the prescription of a prophylactic drug protocol and dental extractions. The intervention g

D03.383.663.283.909.750

Específico

D03.633.100.759.758.824.651.700

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a minimum age of 18 years; undergoing treatment with bone-modifying agents and requiring dental extractions

Exclusion criteria

Exclusion criteria: Patients who have a history of radiotherapy in the head and neck region; patients with obvious maxillary metastasis and patients who do not require tooth extractions

Design outcomes

Primary

Measure	Time frame
To evaluate the presence or absence of osteonecrosis of the jaws, using the method of clinical reassessment of the participants after 01 week, 01 month and 03 months of tooth extraction. It was observed through the intra-oral physical examination, looking for clinical characteristics of osteonecrosis of the jaws, that when present, panoramic radiography of the jaws was requested and its radiographic characteristics were also observed.	—

Measure

Time frame

To evaluate the presence or absence of osteonecrosis of the jaws, using the method of clinical reassessment of the participants after 01 week, 01 month and 03 months of tooth extraction. It was observed through the intra-oral physical examination, looking for clinical characteristics of osteonecrosis of the jaws, that when present, panoramic radiography of the jaws was requested and its radiographic characteristics were also observed.

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Secondary

Measure	Time frame
Side effects associated with the drugs pentoxifylline and tocopherol, measured through participants' reports during the use of the drug protocol.;Influence of systemic risk factors on the occurrence or not of osteonecrosis of the jaw, measured through analysis of the patient's medical record and association with the higher occurrence or not of osteonecrosis of the jaw post-intervention.;Influence of the bone modifying agent used, its dose, route of administration and time of use on the occurrence of osteonecrosis of the jaws, measured through analysis of the patient's medical records and association with the greater occurrence or not of osteonecrosis of the jaws after the intervention.;Sociodemographic data such as age, sex and underlying disease of patients in the occurrence of osteonecrosis of the jaw, measured through analysis of the patient's medical record and association with the higher occurrence or not of osteonecrosis of the jaw post-intervention.	—

Measure

Time frame

Side effects associated with the drugs pentoxifylline and tocopherol, measured through participants' reports during the use of the drug protocol.;Influence of systemic risk factors on the occurrence or not of osteonecrosis of the jaw, measured through analysis of the patient's medical record and association with the higher occurrence or not of osteonecrosis of the jaw post-intervention.;Influence of the bone modifying agent used, its dose, route of administration and time of use on the occurrence of osteonecrosis of the jaws, measured through analysis of the patient's medical records and association with the greater occurrence or not of osteonecrosis of the jaws after the intervention.;Sociodemographic data such as age, sex and underlying disease of patients in the occurrence of osteonecrosis of the jaw, measured through analysis of the patient's medical record and association with the higher occurrence or not of osteonecrosis of the jaw post-intervention.

—

Countries

Brazil

Contacts

Public ContactInstituto Prof. Fernando Figueira

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

comitedeetica@imip.org.br+55-81-21224756

Outcome results

None listed

Source: REBEC (via WHO ICTRP)