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Oral Manifestations in Children With Cancer

Oral Manifestations of Leukemia and Anticancer Treatment in Childhood

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02662465
Enrollment
60
Registered
2016-01-25
Start date
2015-12-31
Completion date
2018-12-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

Keywords

Interventional, Treatment, Laser

Brief summary

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

Detailed description

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm². The assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia. The patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application. Pediatric male or female, diagnosed with cancer who have not yet started cancer treatment, with otherwise healthy oral mucosa in the initial dental exam. Patients who have already started treatment for cancer under radiotherapy or presenting traumatic factors (such as braces or restorations with sharp edges), or presenting ulcers in the mucosa at the initial examination.

Interventions

PROCEDURELaser

Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis.

Sponsors

Universidade Federal do Rio Grande do Norte
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric male or female, diagnosed with cancer who have not yet started cancer treatment, with otherwise healthy oral mucosa in the initial dental exam.

Exclusion criteria

* Patients who have already started treatment for cancer under radiotherapy or presenting traumatic factors (such as braces or restorations with sharp edges), or presenting ulcers in the mucosa at the initial examination.

Design outcomes

Primary

MeasureTime frameDescription
Oral mucositis WHO classificationDuring the first two week evaluationThe assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia.

Secondary

MeasureTime frameDescription
Visual analog scaleA week before and week after the laser applicationThe patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application.

Countries

Brazil

Contacts

Primary ContactBruno CV Gurgel
bcgurgel@yahoo.com.br558499894490
Backup ContactSalomão IML Queiroz
salomaoisral10@gmail.com5584987017068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026