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NCT04608773 · OUTCOME

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 period

What was measured

at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"

Groups in this outcome

Biotene Spray

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

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
Biotene Spray96
Refresh Spray96

Reported measurements

Oral dryness Dryness baseline
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray45.520.3Not reportedNot reportedNot reported
Refresh Spray46.622.7Not reportedNot reportedNot reported
Dryness 2 weeks
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray52.7619.25Not reportedNot reportedNot reported
Refresh Spray54.121.6Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.501
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. group Description
    Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.501
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.3
        value
        45.5
      2. group Id
        OG001
        spread
        22.7
        value
        46.6
    title
    Oral dryness Dryness baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.25
        value
        52.76
      2. group Id
        OG001
        spread
        21.6
        value
        54.1
    title
    Dryness 2 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    units
    Participants
description
at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
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
  2. description
    Participants who received Refresh spray in either the first or second two week period of the study.
    id
    OG001
    title
    Refresh Spray
param Type
MEAN
reporting Status
POSTED
time Frame
2 week trial period
title
Oral Dryness
type
PRIMARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice