Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy

NCT02555501 | Completed Phase 3 DMC

• 1 other identifier: MCCF-060264-AM
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

children; cancer; stomatitis; clinical trial; laser therapy, low-level; methylene blue; photochemotherapy

Outcome Measures

Primary Outcomes (1)

• Lesion size

  Lesion size measured in cm²

  8 days

Study Arms (2)

PDT + Low level laser

EXPERIMENTAL

PDT (photosensitizer and low level laser) and low level laser Photosensitizer: aqueous solution of 0.005% methylene blue; Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)

Other: PDT + Low level laser

Low level laser

ACTIVE COMPARATOR

Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)

Radiation: Low level laser

Interventions

PDT + Low level laser OTHER

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).

PDT + Low level laser

Low level laser RADIATION

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).

Low level laser

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 3 and 18 years old
• Patients on chemotherapy inductive phase
• Patients with oral mucositis and bilateral lesions

You may not qualify if:

• Patients outside the established age
• Patients who are in other phases of chemotherapy
• Patients who did not have bilateral lesions

Sponsors & Collaborators

• Universidade Ceuma: lead
• Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão: collaborator

Study Sites (1)

Hospital Aldenora Bello

São Luís, Maranhão, 65031-630, Brazil

Location

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MeSH Terms

Conditions

Stomatitis; Neoplasms

Interventions

1-phenyl-3,3-dimethyltriazene; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Meire C. Ferreira, PhD

  Programa de Mestrado em Odontologia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matheus Coelho Bandeca

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 21, 2015

Record last verified: 2015-09

Locations

BR (1)