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NCT04608773 · OUTCOME

Swallowing and Chewing 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

Swallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"

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

swallowing baseline
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray Trial53.725.6Not reportedNot reportedNot reported
Refresh Spray Trial54.624.4Not reportedNot reportedNot reported
swallowing 2 weeks
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray Trial62.724.1Not reportedNot reportedNot reported
Refresh Spray Trial60.423.4Not 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
    .213
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .213
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.6
        value
        53.7
      2. group Id
        OG001
        spread
        24.4
        value
        54.6
    title
    swallowing baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.1
        value
        62.7
      2. group Id
        OG001
        spread
        23.4
        value
        60.4
    title
    swallowing 2 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    units
    Participants
description
Swallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? 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
    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
reporting Status
POSTED
time Frame
2 week trial
title
Swallowing and Chewing 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