Oral MucositisNCT07436650
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing high power laser therapy and Basic oral care in people with Oral Mucositis, run by Ain Shams University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- high power laser therapy and Basic oral care
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis.
- Oral mucositis starting from grade II on the WHO scale for OM.
- Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.
Who cannot join
- Previous treatment with photobiomodulation for oral mucositis.
- Limited mouth opening less than 2 cm.
- Presence of dysplastic oral lesions.
- Radiotherapy in the head and neck area.
- Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University
Cairo, Cairo Governorate, +2
About this study
Official title: Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
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 .
- Conditions
- Oral Mucositis
- Being tested
- high power laser therapy, Basic oral care
- Keywords
- Oral Mucositis, High Level Laser Therapy, Hematopoietic Stem cell Transplant
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high power laser therapyDevice
Also called Laser biostimulation, Photobiomodulation therapy
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
Basic oral careDrug
Also called conventional therapy
patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: high power laser therapy |
| 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. Receives: Drug: Basic oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline (day 1), day 7, and day 11 from the start of treatment
Secondary outcomes (1)
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
Measured: at baseline (day 1), day 7, and day 11 from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Jun 2025
- Primary completionAug 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ayman Mohammed Gabr, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436650
- Sponsor's protocol ID
- FDASU-Rec IR/D052511
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07436650
- Acronym / sponsor ID
- FDASU-Rec IR/D052511
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, High Level Laser Therapy, Hematopoietic Stem cell Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power laser therapy group | Experimental | Device: high power laser therapyPediatric 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 | Drug: Basic oral carePediatric 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis.
- Oral mucositis starting from grade II on the WHO scale for OM.
- Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.
Key exclusion criteria (5 listed)
- Previous treatment with photobiomodulation for oral mucositis.
- Limited mouth opening less than 2 cm.
- Presence of dysplastic oral lesions.
- Radiotherapy in the head and neck area.
- Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high power laser therapyAlso: Laser biostimulation, Photobiomodulation therapyhigh 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 | Device | High power laser therapy group |
| Basic oral careAlso: conventional therapypatients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash | Drug | Basic oral care group |
Primary outcome
Oral mucositis score
Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment
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
1 secondary outcome
Pain score
Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high power laser therapy and Basic oral care in people with Oral Mucositis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Ayman Gabr, Teaching Assistant (+2 01095692889, Asmaagabr@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis score (time frame: at baseline (day 1), day 7, and day 11 from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.