Participant flow

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.

groups

1. description

   The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray

   id

   FG000

   title

   Biotene Spray, Followed by Refresh Spray

2. description

   The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed) Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray

   id

   FG001

   title

   Refresh Spray, Followed by Biotene Spray

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         60

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         54

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         6

      type

      NOT COMPLETED

   title

   First Wash Out (1 Week)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      mild adverse effects

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         54

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         50

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      NOT COMPLETED

   title

   First Intervention (2 Weeks)

3. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         50

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         50

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Second Wash Out (1 Week)

4. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      mild adverse effect

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         50

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         51

      2. group Id

         FG001

         num Subjects

         45

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      NOT COMPLETED

   title

   Second Intervention (2 Week)

pre Assignment Details

468 patients were found eligible, 339 declined to participate and 129 were enrolled.

recruitment Details

1824 patients were screened for eligibility at UPMC's Head and Neck Cancer Survivorship Clinic between January 2021 and September 2022.

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Preserved source evidence · Not medical advice