Mucositis Clinical Trial
Official title:
EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
NCT number | NCT05181943 |
Other study ID # | 332021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | December 1, 2021 |
Verified date | December 2021 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia
Status | Completed |
Enrollment | 44 |
Est. completion date | December 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: - children diagnosed with mucositis and receiving chemotherapy Exclusion Criteria: - diabetes - trismus |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported pain level | Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level. | up to 2 weeks | |
Primary | Oral mucositis lesion size | This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake.
Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition. |
up to 2 weeks |
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