Analysis of the Oral Environment in patients treated with Laser Therapy for Oral Mucositis

Analysis of the Oral Microbiome in patients treated with Photobiomodulation for Oral Mucositis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-9brv7dd

Enrollment

Unknown

Registered

2025-06-28

Start date

2024-10-22

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

Radiotherapy

Interventions

This is a longitudinal prospective randomized experimental study. The aim was to evaluate the oral microbiome of patients treated with intraoral and extraoral photobiomodulation (PB) in the management

on the 15th day after the start of treatment (T2)

on the 25th day after the start of treatment (T3)

at the last session of RT (which normally varies between 33 and 35 sessions) (T4) and 30 days after the end of RT (T5), coinciding with their return to the institution for their routine procedures.

E02.594.540

Eligibility

Inclusion criteria

Inclusion criteria: Patients with malignant neoplasms in the head and neck region; undergoing radiotherapy treatment; both genders; no minimum or maximum age limit

Exclusion criteria

Exclusion criteria: Patients undergoing chemotherapy; uncontrolled or severe periodontal disease; application of oral topical medication; use of systemic corticosteroids; anti-inflammatory therapy; patients with salivary gland tumors; surgical removal of major salivary glands

Design outcomes

Primary

Measure	Time frame
To evaluate the frequency and severity of oral mucositis, as well as pain intensity, in the two intervention groups (intraoral laser and extraoral laser), using the mucositis grade scale (WHO and NCI) and visual analog scale (VAS) with a score of 0 to 10 to evaluate pain intensity. To evaluate the frequency and severity of hyposalivation, as well as the subjective parameters of xerostomia, in the two intervention groups, through sialometry and subjective parameters of xerostomia through a questionnaire made up of 8 items, which make up the main subjective aspects related to salivary production: dryness of the oral mucosa (lips, mouth, tongue or throat) and oral functional capacity caused by dryness (difficulty swallowing and speaking). In addition, there are 2 global items on dry mouth (amount of saliva in the mouth or level of thirst), scored using the visual analog scale. It is expected that extraoral photobiomodulation will be effective in reducing the severity of oral mucositis, pain intensity and the severity of hyposalivation in patients undergoing head and neck radiotherapy. It is also hoped that extraoral photobiomodulation will be more accepted by patients who have difficulty opening their mouths due to radiotherapy treatment and the degree of mucositis, and that it will take less time to apply.	—

Measure

Time frame

To evaluate the frequency and severity of oral mucositis, as well as pain intensity, in the two intervention groups (intraoral laser and extraoral laser), using the mucositis grade scale (WHO and NCI) and visual analog scale (VAS) with a score of 0 to 10 to evaluate pain intensity. To evaluate the frequency and severity of hyposalivation, as well as the subjective parameters of xerostomia, in the two intervention groups, through sialometry and subjective parameters of xerostomia through a questionnaire made up of 8 items, which make up the main subjective aspects related to salivary production: dryness of the oral mucosa (lips, mouth, tongue or throat) and oral functional capacity caused by dryness (difficulty swallowing and speaking). In addition, there are 2 global items on dry mouth (amount of saliva in the mouth or level of thirst), scored using the visual analog scale. It is expected that extraoral photobiomodulation will be effective in reducing the severity of oral mucositis, pain intensity and the severity of hyposalivation in patients undergoing head and neck radiotherapy. It is also hoped that extraoral photobiomodulation will be more accepted by patients who have difficulty opening their mouths due to radiotherapy treatment and the degree of mucositis, and that it will take less time to apply.

—

Secondary

Measure	Time frame
Evaluate patients' quality of life using a validated questionnaire from the European Organization for Research and Treatment of Cancer (EORTC) (EORTC QLQ-HN35) and analysis of the oral microbiome through salivary collections taken throughout the period and stored at -20 degrees Celsius for later analysis. It is expected that patients who receive intraoral and extraoral photobiomodulation will show a significant improvement in their quality of life during cancer treatment.	—

Measure

Time frame

Evaluate patients' quality of life using a validated questionnaire from the European Organization for Research and Treatment of Cancer (EORTC) (EORTC QLQ-HN35) and analysis of the oral microbiome through salivary collections taken throughout the period and stored at -20 degrees Celsius for later analysis. It is expected that patients who receive intraoral and extraoral photobiomodulation will show a significant improvement in their quality of life during cancer treatment.

—

Countries

Brazil

Contacts

Public ContactMelissa de Araújo

Universidade Federal do Paraná

melissararaujo@ufpr.br55 (41) 3360-4050

Outcome results

None listed

Source: REBEC (via WHO ICTRP)