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NCT04608773 · OUTCOME

Taste Alteration/Impairment Due to Oral Dryness

Blinded Dry Mouth Spray Crossover Study · Source last updated 2024-02-01

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
2 week trial

What was measured

Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected"

Analysis population: The number of participants in this analysis are lower than the overall population due to missing data.

Groups in this outcome

Biotene Spray Trial

Participants who received Biotene in either the first or last two week trial period of the study.

Refresh Spray Trial

Participants who received Refresh spray in either the first or second two week trial period of the study.

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

Analysis denominator · Participants

GroupSource count
Biotene Spray Trial96
Refresh Spray Trial96

Reported measurements

Taste baseline

Analysis denominator · Participants

GroupSource count
Biotene Spray Trial91
Refresh Spray Trial91
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray Trial73.229.0Not reportedNot reportedNot reported
Refresh Spray Trial71.529.3Not reportedNot reportedNot reported
Taste 2 weeks

Analysis denominator · Participants

GroupSource count
Biotene Spray Trial96
Refresh Spray Trial96
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray Trial78.122.8Not reportedNot reportedNot reported
Refresh Spray Trial75.427.0Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .489
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .489
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.0
        value
        73.2
      2. group Id
        OG001
        spread
        29.3
        value
        71.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Taste baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.8
        value
        78.1
      2. group Id
        OG001
        spread
        27.0
        value
        75.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    Taste 2 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    units
    Participants
description
Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected"
dispersion Type
Standard Deviation
groups
  1. description
    Participants who received Biotene in either the first or last two week trial period of the study.
    id
    OG000
    title
    Biotene Spray Trial
  2. description
    Participants who received Refresh spray in either the first or second two week trial period of the study.
    id
    OG001
    title
    Refresh Spray Trial
param Type
MEAN
population Description
The number of participants in this analysis are lower than the overall population due to missing data.
reporting Status
POSTED
time Frame
2 week trial
title
Taste Alteration/Impairment Due to Oral Dryness
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice