se of Pentoxifylline and Tocopherol before Tooth Extractions in Cancer patients undergoing treatment with bone Medications
- Conditions
- OncologyOsteonecrosis
- Registration Number
- RBR-52ynn6j
- Brief Summary
Bone modifying agents (antiresorptives) have the function of reducing excessive bone resorption by decreasing the activity and/or number of osteoclasts. Among them, the class of bisphosphonates and denosumab stand out, both of which are associated with the development of drug-related osteonecrosis of the jaw (MRONJ), especially when bone tissue is manipulated. Given the need to perform tooth extraction in patients undergoing such medications, the greatest concern is the risk of MRONJ. The association of pentoxifylline and tocopherol has been shown to be beneficial in the treatment of MRONJ and its prophylactic use has been shown in osteoradionecrosis, however, there is a paucity of studies in MRONJ. In light of this problem, the aim of this study is to evaluate the prophylactic effect of pentoxifylline and tocopherol on MRONJ in patients undergoing tooth extraction in the face of treatment with bone-modifying agents. The research will be developed by a single researcher at the dental clinic of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), from April 2021 to February 2022. Patients will be screened through the daily medication schedule of the IMIP oncology outpatient clinic and through internal referral, for 05 months. Patients who meet the established eligibility criteria will participate in the research. Prior to performing the tooth extraction, a prophylactic drug protocol for MRONJ will be prescribed. The patient will be reassessed for a period of 01 week, 01 month and 03 months after the extraction. The data collected will be recorded in a specific form, which will later be tabulated in a Microsoft Excel 2016 spreadsheet and subjected to statistical analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients with a minimum age of 18 years; undergoing treatment with bone-modifying agents and requiring dental extractions
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.