Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy

NCT02555501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-09-21

No results posted yet for this study

Summary

The aim of the study was to evaluate the therapeutic action through the diameter of the lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT + LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own control. Patients were masked about therapy performed on each side of the arch. The evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect magnitude calculated. The significance level was 5%. Statistically significant difference was observed between the groups for the lesion diameter of the 6th to the 8th day (greater regression of lesion size for the PDT + LLL group), which was confirmed by a difference magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater therapeutic effect when compared to LLL in reducing the severity of OM lesions.

Conditions

  • Oral Mucositis

Interventions

OTHER

PDT + Low level laser

Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment was pigmented with aqueous solution of 0.005% methylene blue. A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium). From the 3rd to the 10th day was carried out only laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).

RADIATION

Low level laser

Two days before the laser treatment, the lesion of the side of the oral cavity chosen for the control treatment was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. From the 3rd to the 10th day was carried out laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

    collaborator UNKNOWN
  • Universidade Ceuma

    lead OTHER

Principal Investigators

  • Meire C. Ferreira, PhD · Programa de Mestrado em Odontologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555501 on ClinicalTrials.gov