The effects os the Dental Treatment for the patients with Head and Neck Cancer

Phase 3

• Conditions: Head and Neck Neoplasms; D003729

• Registration Number: RBR-62f6qwh
• Lead Sponsor: niversidade do Estado do Rio de Janeiro

Brief Summary

The Low-Laser-Light- Therapy associated with a professional dental care protocol, which included an adequate and strict periodontal therapy, reduced the inflammatory process and the OM severity. An increased level of the growth factors and anti-inflammatory cytokines was observed, associated with a decrease in pro-inflammatory cytokines.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-01
• Study Start: 2022-10-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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).

Secondary Outcome Measures

Name	Time	Method
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.;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.