Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02555501
• Date of registration: 17/09/2015
• Prospective Registration: No
• Primary sponsor: Universidade Ceuma
• Public title: Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy OMLTPT
• Scientific title: Laser Therapy Associated With Photodynamic Therapy in the Treatment of Oral Mucositis Induced by Chemotherapy in Young Patients: Randomized Blind Clinical Trial
• Date of first enrolment: October 2014
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555501
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Meire C. Ferreira, PhD
• Affiliation: Programa de Mestrado em Odontologia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients between 3 and 18 years old

- Patients on chemotherapy inductive phase

- Patients with oral mucositis and bilateral lesions

Exclusion Criteria:

- Patients outside the established age

- Patients who are in other phases of chemotherapy

- Patients who did not have bilateral lesions



Age minimum: 3 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Oral Mucositis

Intervention(s)

Radiation: Low level laser

Other: PDT + Low level laser

Primary Outcome(s)

Lesion size [Time Frame: 8 days]

Secondary ID(s)

MCCF-060264-AM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão