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临床试验/CTRI/2026/03/105972
CTRI/2026/03/105972尚未招募不适用

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

Dr Samrudhi Sanjay Sawant1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

研究者

发起方
Dr Samrudhi Sanjay Sawant
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Samrudhi Sanjay Sawant

Yenepoya Dental College, Mangalore

研究点 (1)

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