Trial Outcomes & Findings for Dentine Tubule Occlusion Assessment in a Modified in Situ Model (NCT NCT02768194)
NCT ID: NCT02768194
Last Updated: 2018-06-25
Results Overview
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline and Day 8
Results posted on
2018-06-25
Participant Flow
Participants were recruited at one center at United Kingdom.
A total of 26 participants were screened, out of which 24 participants were randomized to the study and 2 participants withdrawn their consent.
Participant milestones
| Measure |
Test /Negative Control/Reference
Firstly, participants received dentifrice containing 0.454% stannous fluoride (test), secondly mineral water (negative control) and thirdly dentifrice containing 0.76% sodium monofluorophosphate (reference). Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 milliliters (mL) of mineral water for 5 seconds.
|
Test/Reference/Negative Control
Firstly, participants received test dentifrice, secondly reference dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control/Test/Reference
Firstly, participants received negative control, secondly test dentifrice and thirdly reference dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control/Reference/Test
Firstly, participants received negative control, secondly reference dentifrice and thirdly test dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference/Test/Negative Control
Firstly, participants received reference dentifrice, secondly test dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference/Negative Control/Test
Firstly, participants received reference dentifrice, secondly negative control and thirdly test dentrifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period 1
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 2
STARTED
|
4
|
4
|
4
|
3
|
4
|
4
|
|
Period 2
COMPLETED
|
3
|
4
|
4
|
3
|
4
|
4
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
3
|
4
|
4
|
3
|
4
|
4
|
|
Period 3
COMPLETED
|
3
|
3
|
4
|
3
|
4
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test /Negative Control/Reference
Firstly, participants received dentifrice containing 0.454% stannous fluoride (test), secondly mineral water (negative control) and thirdly dentifrice containing 0.76% sodium monofluorophosphate (reference). Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 milliliters (mL) of mineral water for 5 seconds.
|
Test/Reference/Negative Control
Firstly, participants received test dentifrice, secondly reference dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control/Test/Reference
Firstly, participants received negative control, secondly test dentifrice and thirdly reference dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control/Reference/Test
Firstly, participants received negative control, secondly reference dentifrice and thirdly test dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference/Test/Negative Control
Firstly, participants received reference dentifrice, secondly test dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference/Negative Control/Test
Firstly, participants received reference dentifrice, secondly negative control and thirdly test dentrifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 2
Other (Reason not specified)
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Other (Reason not specified)
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dentine Tubule Occlusion Assessment in a Modified in Situ Model
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=24 Participants
All randomized participants were included for baseline evaluation.
|
|---|---|
|
Age, Continuous
|
41.4 Years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 8Population: Per protocol (PP) Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Outcome measures
| Measure |
Test Product
n=23 Participants
Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference Product
n=22 Participants
Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control
n=24 Participants
Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
|---|---|---|---|
|
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Pre-dose (Baseline)
|
4.38 Score on a scale
Standard Deviation 0.383
|
4.32 Score on a scale
Standard Deviation 0.518
|
4.36 Score on a scale
Standard Deviation 0.398
|
|
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Post-dose (Post Baseline)
|
3.43 Score on a scale
Standard Deviation 0.760
|
3.42 Score on a scale
Standard Deviation 0.754
|
3.53 Score on a scale
Standard Deviation 0.865
|
|
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Change
|
-0.95 Score on a scale
Standard Deviation 0.925
|
-0.90 Score on a scale
Standard Deviation 0.933
|
-0.83 Score on a scale
Standard Deviation 0.849
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 4, and 10Population: PP Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Outcome measures
| Measure |
Test Product
n=23 Participants
Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference Product
n=22 Participants
Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control
n=24 Participants
Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
|---|---|---|---|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 4: Post-dose (Post Baseline)
|
3.51 Score on a scale
Standard Deviation 0.825
|
3.60 Score on a scale
Standard Deviation 0.843
|
3.98 Score on a scale
Standard Deviation 0.762
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 10: Change from Baseline
|
-1.18 Score on a scale
Standard Deviation 0.910
|
-0.82 Score on a scale
Standard Deviation 0.827
|
-0.62 Score on a scale
Standard Deviation 0.958
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 1: Pre-dose (Baseline)
|
4.30 Score on a scale
Standard Deviation 0.424
|
4.38 Score on a scale
Standard Deviation 0.364
|
4.30 Score on a scale
Standard Deviation 0.486
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 1: Post-dose (Post Baseline)
|
3.96 Score on a scale
Standard Deviation 0.578
|
4.13 Score on a scale
Standard Deviation 0.769
|
3.86 Score on a scale
Standard Deviation 0.961
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 1: Change from Baseline
|
-0.34 Score on a scale
Standard Deviation 0.723
|
-0.26 Score on a scale
Standard Deviation 0.748
|
-0.44 Score on a scale
Standard Deviation 0.876
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 4: Pre-dose (Baseline)
|
4.41 Score on a scale
Standard Deviation 0.465
|
4.30 Score on a scale
Standard Deviation 0.466
|
4.23 Score on a scale
Standard Deviation 0.404
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 4: Change from Baseline
|
-0.91 Score on a scale
Standard Deviation 0.819
|
-0.70 Score on a scale
Standard Deviation 0.875
|
-0.25 Score on a scale
Standard Deviation 0.827
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 10: Pre-dose (Baseline)
|
4.31 Score on a scale
Standard Deviation 0.410
|
4.31 Score on a scale
Standard Deviation 0.418
|
4.36 Score on a scale
Standard Deviation 0.428
|
|
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Day 10: Post-dose (Post Baseline)
|
3.13 Score on a scale
Standard Deviation 0.958
|
3.49 Score on a scale
Standard Deviation 0.841
|
3.74 Score on a scale
Standard Deviation 0.862
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Negative Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=23 participants at risk
Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Reference Product
n=22 participants at risk
Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
Negative Control
n=24 participants at risk
Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds.
|
|---|---|---|---|
|
Gastrointestinal disorders
Sensitivity of Teeth
|
0.00%
0/23 • Baseline to Day 10
|
0.00%
0/22 • Baseline to Day 10
|
4.2%
1/24 • Number of events 1 • Baseline to Day 10
|
|
General disorders
Pyrexia
|
0.00%
0/23 • Baseline to Day 10
|
4.5%
1/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/23 • Baseline to Day 10
|
4.5%
1/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/23 • Baseline to Day 10
|
4.5%
1/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/23 • Baseline to Day 10
|
4.5%
1/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/23 • Baseline to Day 10
|
0.00%
0/22 • Baseline to Day 10
|
8.3%
2/24 • Baseline to Day 10
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
4.3%
1/23 • Baseline to Day 10
|
4.5%
1/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.3%
1/23 • Baseline to Day 10
|
0.00%
0/22 • Baseline to Day 10
|
0.00%
0/24 • Baseline to Day 10
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER