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N/A N=40 Randomized Single-blind Treatment

Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Xerostomia

Enrolled (actual)
40
Serious AEs
1.3%
Results posted
Nov 2020
Primary outcome: Primary: 10 cm Mouth Dryness Visual Analog Score — 4.51; 4.6 cm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray (Device); Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Solventum US LLC
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
10 cm Mouth Dryness Visual Analog Score
-2.364; -1.657
SECONDARY
10 cm Mean Mouth Dryness Visual Analog Score
4.54; 4.62
SECONDARY
10 cm Mouth Dryness Visual Analog Score
-2.364; -1.657
SECONDARY
10 cm Mean Mouth Dryness Visual Analog Score
4.54; 4.62
SECONDARY
10 cm Mean Mouth Dryness Visual Analog Scale
4.86; 5.41
SECONDARY
10 cm Mean Mouth Dryness Visual Analog Scale
4.86; 5.41
SECONDARY
10 cm Mean Mouth Dryness Visual Analog Scale
4.86; 5.41
SECONDARY
10 cm Mouth Dryness Visual Analog Scale
-2.420; -1.900
SECONDARY
10 cm Mouth Dryness Visual Analog Scale
-2.420; -1.900
SECONDARY
10 cm Mouth Dryness Visual Analog Scale
-2.420; -1.900
SECONDARY
10 cm Mouth Dryness Visual Analog Score
-2.364; -1.657
SECONDARY
10 cm Mouth Dryness Visual Analog Score
-2.364; -1.657
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response on Dry Mouth Relief
6; 6; 13; 16; 12; 11
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Effectively Lubricates the Mouth
9; 9; 14; 18; 10; 6
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Feel Comfortable in the Mouth
5; 6; 14; 14; 12; 11
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Soothing in the Mouth
7; 8; 16; 15; 8; 9
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5
SECONDARY
Response to Effectively Moistens the Mouth
12; 8; 12; 20; 8; 5

Summary

The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.

Eligibility Criteria

Inclusion Criteria

Screening - Start of Wash-In Visit

  • Subject who is ≥18 years of age and complains of dry mouth
  • Only 1 subject per household is allowed into study
  • Subject with a Challacombe scale score of 1 or higher
  • Subject agrees to refrain from eating spicy foods and foods containing garlic beginning 48-hours prior to all study visits
  • Subject agrees to eat a meal prior to all study visits that include sample evaluation in the clinic
  • Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss teeth for 2-hours prior to sample evaluation study visits
  • Subject agree to not use any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject agrees to only use those clinical oral care supplies provided during the entire study
  • Able to understand and willing to sign the Informed Consent Form

Water Only Evaluation Visit

  • Subject has successfully completed a ≥ 2-day wash-in period
  • Subject has Challacombe scale score of 1 or higher
  • Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to the sample evaluation visits
  • Subject ate a meal prior to sample evaluation study visits
  • Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
  • Subject has not used any oral care products, any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject has used only those clinical oral care supplies provided during study

Baseline Period 1/Randomization Visit

  • Subject has successfully completed a ≥ 2-day wash-in period
  • Subject has a Challacombe Scale score of 1 or higher
  • Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to sample evaluation study visits
  • Subject ate a meal prior to sample evaluation study visits
  • Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
  • Subject has not used any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject has used only those clinical oral care supplies provided during study

Exclusion Criteria

Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)

  • Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores)
  • Subject has a life-threatening pathological condition
  • Subject is participating in another clinical trial at the time of the study
  • Subject has profound marginal periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
  • Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
  • Difficult to be compliant with recalls, such as extensive travel commitments, lack of transportation etc.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04186806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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