Periodontitis
Conditions
Interventions
This is a randomized, controlled, two-arm, double-blind clinical study. The total number of participants will be 312, already accounting for potential dropouts and losses. Each group will include 156
Sponsors
Universidade do Estado do Rio de Janeiro - UERJ
Universidade do Estado do Rio de Janeiro - UERJ
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Head and neck cancer patients aged 18 years or older; patients diagnosed with periodontal health or periodontitis stages I, II, III, or IV; Patients who will undergo head and neck radiotherapy as part of the oncologic treatment plan for head and neck cancer
Exclusion criteria
Exclusion criteria: Patients under 18 years old; Patients who have received dental treatment within the six months preceding recruitment; Pacients who have previously undergone radiotherapy or chemotherapy; Patients who are currently using bone resorption inhibitors or immunosuppressive drugs
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| A 50% lower concentration of inflammatory biomarkers obtained from unstimulated saliva samples (interleukin-1, interleukin-6, and tumor necrosis factor-alpha) is expected in the test group compared with the control group after the completion of radiotherapy, as determined by Luminex immunoassay analysis. In addition, a lower count of periodontal microbiota bacteria is expected in the test group, as determined by PCR (polymerase chain reaction) analysis, compared with the control group. | — |
Primary
| Measure | Time frame |
|---|---|
| O ChatGPT disse: A reduction of approximately 50% in the prevalence of radiotherapy-induced oral mucositis lesions is expected among patients who undergo periodontal treatment prior to head and neck radiotherapy. Furthermore, regarding the clinical severity of radiotherapy-induced oral mucositis, as assessed by the Radiation Therapy Oncology Group (RTOG) classification system, the absence of grade IV (severe) ulcerations is anticipated. | — |
Countries
Brazil
Contacts
Public ContactRodrigo de Oliveira
Universidade do Estado do Rio de Janeiro - UERJ
Outcome results
None listed