CTRI

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CTRI Number

CTRI/2026/03/105972 [Registered on: 11/03/2026] Trial Registered Prospectively

Last Modified On:

04/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Use of lasers to prevent oral mucositis in children 2 to 15 years old receiving cancer treatment

Scientific Title of Study

Effectiveness of photobiomodulation pre-conditioning for prevention of oral mucositis in children aged between 2 to 15 years receiving chemotherapy - a randomized controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Samrudhi Sanjay Sawant
Designation	Post Graduate Student
Affiliation	Yenepoya Dental College, Mangalore
Address	Department of Pediatric and Preventive Dentistry, first floor, Yenepoya Dental College, University Road, Deralakatte, Mangalore 1603 A Block, Siliconia Apartment, Kuthar Padavu, Permanur, Ullal, Karnatak Dakshina Kannada KARNATAKA 575018 India
Phone	8806997666
Fax
Email	samrudhis510@gmail.com

Details of Contact Person
Scientific Query

Name	Dr H T Ajay Rao
Designation	Pediatric Dentist
Affiliation	Yenepoya Dental College, Mangalore
Address	Department of Pediatric and Preventive Dentistry, first floor, Yenepoya Dental College, University Road, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9845085048
Fax
Email	drajayrao@gmail.com

Details of Contact Person
Public Query

Name	Dr H T Ajay Rao
Designation	Pediatric Dentist
Affiliation	Yenepoya Dental College, Mangalore
Address	Department of Pediatric and Preventive Dentistry, first floor, Yenepoya Dental College, University Road, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9845085048
Fax
Email	drajayrao@gmail.com

Source of Monetary or Material Support

Yenepoya Dental College and Hospital, Deralakatte, Mangalore 575018, Karnataka, India

Primary Sponsor

Name	Dr Samrudhi Sanjay Sawant
Address	Yenepoya Dental College, University Road, Deralakatte, Mangalore, 575018, Karnataka, Inida
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Samrudhi Sanjay Sawant	Yenepoya Zulekha Institute of Oncology	Hemat-oncology Ward, Yenepoya Zulekha Institute of Oncology Dakshina Kannada KARNATAKA	8806997666 samrudhis510@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
YENEPOYA ETHICS COMMITTEE 2	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C96Z\|\|Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Basic oral care instructions.	Before the start of the first chemotherapy session, informed consent will be obtained from all participants included in the study. Basic oral care instructions will be provided both verbally and in writing. These instructions will include brushing teeth for 90 seconds using a soft toothbrush, using dental floss, rinsing the mouth with chlorhexidine mouthwash, application of antifungal cream/gel, drinking plenty of water, brushing teeth after meals, and avoiding hot or cold beverages and spicy, sour, or hard foods. [24,25] Instructions will be explained to parents/caregivers. Audiovisual aids will be used to help explain the oral care procedures, and parents will be provided with appropriate educational videos (such as verified online video links) for better understanding and reinforcement of instructions. Parents will assist or perform oral care for younger children (2–6 years).
Intervention	Laser Photobiomodulation	Patients will receive the basic oral care instructions, in addition to intraoral photobiomodulation with a diode laser (650 nm; power 100 mW, energy density 6 J/cm² The number of irradiation points are as follows: 8 on the buccal mucosa (4 on each side), 4 on the labial mucosa (2 upper and 2 lower), 8 on the tongue (3 on the right side, 3 on the left side, and 2 on the ventral surface), 2 on the floor of the mouth, and 2 on the soft palate. These treatments will be performed before the start of the first chemotherapy session (on the same day).

Inclusion Criteria

Age From	2.00 Year(s)
Age To	15.00 Year(s)
Gender	Both
Details	1.Children between the age group of 2-15 years who are admitted to Zulekha Institute of Oncology with leukaemias, lymphomas, or solid tumours are recommended to receive chemotherapy. 2.No existing oral mucosal lesions at baseline. 3.Ability to comply with follow-up.

ExclusionCriteria

Details

1. Prior radiotherapy to the head and neck region.
2. Malignancy of the oral cavity.
3. Juvenile Diabetes.
4. Undergoing any other procedures to prevent oral Mucositis
5. Children unwilling or unable to participate.

Method of Generating Random Sequence

Other

Method of Concealment

Alternation

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Occurrence and severity of oral mucositis Measurement Tool: Oral Mucositis Assessment Scale (OMAS) Parameters Assessed: Erythema (0–2) Ulceration/pseudomembrane (0–3) Total OMAS score (0–5) Average score across all intraoral sites	7 days and 14 days after initiation of first chemotherapy cycle

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/04/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Oral mucositis (OM) is one of the most painful and debilitating complications experienced by patients undergoing chemotherapy, with incidence rates particularly being elevated in children. OM impacts 40–100% of patients based on cancer type and treatment modality, pediatric patients exhibit even greater susceptibility, with literature estimating rates as high as 52–80% substantially exceeding compared with 40-76% in adult populations receiving similar therapies. It significantly affects nutrition, oral hygiene, speech, and overall quality of life.

Photobiomodulation (PBM), also known as low-level laser therapy, is a non-invasive technique that uses light in the visible to near-infrared spectrum to influence biological processes. It has garnered attention due to its analgesic, anti-inflammatory, and regenerative effects, while being safer and more child-friendly compared to pharmacological approaches.

This study proposes a randomized controlled trial to evaluate the effectiveness of laser photobiomodulation preconditioning in reducing the occurrence of oral mucositis in children receiving chemotherapy, compared to routine oral hygiene practices alone. These findings may help establish a non-invasive, safe, and effective preventive strategy for children undergoing chemotherapy.