Head and Neck Neoplasms
Conditions
Interventions
This is a double-blind, 3-arms, randomized clinical trial.Randomization in blocks of four will be performed using opaque envelopes placed in the IDs of the treatment group. The envelopes will be seale
and oral mucositis prophylaxis by the low laser light therapy and photobiomodulation (Aluminum and Gallium Arsenide laser and Diode laser) applied five times a week while the antineoplastic treatment
E02.594
Sponsors
Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro
Universidade do Estado do Rio de Janeiro
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Presence of tumors in the oral cavity that needed radiotherapy, with or without chemotherapy; age higher than 18 years old; and presence of at least 6 natural teeth, excluding third molars
Exclusion criteria
Exclusion criteria: Patients previously submitted to radiotherapy or chemotherapy; patients on non-oral feeding ways; patients using antiresorptive drugs; and patients that received dental treatment in the past 6 months before the first observational period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed Outcome 1: A significantly higher severity of Oral Mucositis was found in group 3 (only received laser therapy) when compared to groups 1 and 2 (received dental treatment associated with laser therapy).;Expected outcome 1: We expect a reduction of oral mucositis severity, measured by the World Health Organization's Oral Mucositis Index, in groups that received dental treatment associated with laser therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: We expect to observe an increase of IL2, IL4, IL8, IL10 and TNFa and a reduction of IL6 in the experimental groups 1 and 2. Furthermore, we expect changes in BFGF, GM-CSF, PDGF-BB, VEGF and M-CSF levels.;Observed outcome 2: A significantly higher increase in TNFa was found for groups 1 and 2, when compared to baseline. The mean levels of IL6 were significantly lower in all groups. In group 1, the mean values of IL2, IL4, IL8 and IL10 were significantly higher when compared to baseline. Furthermore, it was observed that group 1 had significantly higher levels of BFGF, GM-CSF and PDGF-BB. No changes were observed in VEGF and M-CSF levels. | — |
Countries
Brazil
Contacts
Public ContactRaquel Lima de Andrade Pontes
Universidade do Estado do Rio de Janeiro
Outcome results
None listed