Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04608773 · OUTCOME

Speaking Difficulty 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

Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

Analysis population: The number of participants in analysis are lower in this specific analysis due to missing data

Groups in this outcome

Speaking Difficulty Score After Biotene Spray

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

Speaking Difficulty Score After Refresh Spray

Participants who received Refresh spray in either the first or second two week 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
Speaking Difficulty Score After Biotene Spray96
Speaking Difficulty Score After Refresh Spray96

Reported measurements

speaking baseline

Analysis denominator · Participants

GroupSource count
Speaking Difficulty Score After Biotene Spray91
Speaking Difficulty Score After Refresh Spray91
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Speaking Difficulty Score After Biotene Spray60.827.6Not reportedNot reportedNot reported
Speaking Difficulty Score After Refresh Spray63.026.6Not reportedNot reportedNot reported
speaking 2 weeks

Analysis denominator · Participants

GroupSource count
Speaking Difficulty Score After Biotene Spray96
Speaking Difficulty Score After Refresh Spray96
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Speaking Difficulty Score After Biotene Spray69.922.2Not reportedNot reportedNot reported
Speaking Difficulty Score After Refresh Spray66.824.1Not 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
    .107
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .107
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.6
        value
        60.8
      2. group Id
        OG001
        spread
        26.6
        value
        63.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    speaking baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.2
        value
        69.9
      2. group Id
        OG001
        spread
        24.1
        value
        66.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    speaking 2 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    units
    Participants
description
Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"
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
    Speaking Difficulty Score After Biotene Spray
  2. description
    Participants who received Refresh spray in either the first or second two week period of the study.
    id
    OG001
    title
    Speaking Difficulty Score After Refresh Spray
param Type
MEAN
population Description
The number of participants in analysis are lower in this specific analysis due to missing data
reporting Status
POSTED
time Frame
2 week trial
title
Speaking Difficulty 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