Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01439724 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      47
    2. group Id
      BG001
      value
      47
    3. group Id
      BG002
      value
      94
    units
    Participants
groups
  1. 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
    BG000
    title
    Placebo
  2. 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
    BG001
    title
    Low Level Laser Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.6
          value
          55.7
        2. group Id
          BG001
          spread
          6.9
          value
          53.5
        3. group Id
          BG002
          spread
          7.7
          value
          54.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          82
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          94
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The primary end point of the study was the incidence of grade 3-4 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.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      47
    2. group Id
      BG001
      value
      47
    3. group Id
      BG002
      value
      94
    units
    Participants
groups
  1. 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
    BG000
    title
    Placebo
  2. 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
    BG001
    title
    Low Level Laser Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.6
          value
          55.7
        2. group Id
          BG001
          spread
          6.9
          value
          53.5
        3. group Id
          BG002
          spread
          7.7
          value
          54.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          82
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          94
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The primary end point of the study was the incidence of grade 3-4 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.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice