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The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is :
Is high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale.
Participants will be subjected to high level laser on lesion sites .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High power laser therapy group | Experimental | Pediatric bone marrow transplantation patients with oral mucositis will receive high-power laser therapy once daily for four consecutive days. The laser parameters will be a wavelength of 660 to 970 nm, of power 3.2 w, pulsed at 50% duty cycle, spot size of 1 cm2, for 230 sec, defocused mode. |
|
| Basic oral care group | Active Comparator | Pediatric bone marrow transplantation patients with oral mucositis will receive standard basic oral care. Local methods: mouth rinse chlorohexidine three times a day, sodium bicarbonate mouthwash. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high power laser therapy | Device | high power laser therapy once daily for four consecutive days with wavelength 660 to 970 nm, power 3.2 w, and duration of 230 seconds at 50% duty cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Oral mucositis score | World Health Organization (WHO) scale of oral mucositis will be used to describe the lesions at baseline, day 7 and day 11, lesions are given grades from 1 to 4, with 4 being a worse outcome | at baseline (day 1), day 7, and day 11 from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain visual analogue scale will be used to measure pain level, where the patient will be given a diagram representing pain levels from 1 to 10, 10 being the highest level of pain | at baseline (day 1), day 7, and day 11 from the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa Ayman Gabr, Teaching Assistant | Contact | +2 01095692889 | Asmaagabr@dent.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University | Recruiting | Cairo | Cairo Governorate | +2 | Egypt |
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| Basic oral care | Drug | patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash |
|
|
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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