NCT01439724 · OUTCOME

Incidence and / or Severity of Oral Mucositis

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients · Source last updated 2014-04-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Grade 3-4 oral mucositis
Interval / dispersion: Not reported
Time frame: 7 weeks

What was measured

The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.

Analysis population: Data related to the primary endpoint were handled in a per protocol treatment analysis.

Groups in this outcome

Placebo

Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light. Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.

Low Level Laser Therapy

The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region. Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Placebo	47
Low Level Laser Therapy	47

Reported measurements

Source class 1

Values in Grade 3-4 oral mucositis · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	19	Not reported	Not reported	Not reported	Not reported
Low Level Laser Therapy	3	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.050
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.498
group Description
The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.05
param Type
Risk Ratio (RR)
param Value
0.158
statistical Method
Chi-squared
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.050
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.498
group Description
The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.05
param Type
Risk Ratio (RR)
param Value
0.158
statistical Method
Chi-squared
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
19
group Id
OG001
value
3

denoms

counts
group Id
OG000
value
47
group Id
OG001
value
47
units
Participants

description

groups

description
Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light. Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
id
OG000
title
Placebo
description
The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region. Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
id
OG001
title
Low Level Laser Therapy

param Type

NUMBER

population Description

Data related to the primary endpoint were handled in a per protocol treatment analysis.

reporting Status

POSTED

time Frame

7 weeks

title

Incidence and / or Severity of Oral Mucositis

type

PRIMARY

unit Of Measure

Grade 3-4 oral mucositis

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Preserved source evidence · Not medical advice