Dentin Sensitivity
Conditions
Brief summary
This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.
Detailed description
This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.
Interventions
DEVICEStannous fluoride
Dentifrice containing 0.454% stannous fluoride
Dentifrice containing 0.76% sodium monofluorophosphate
OTHERMineral water
Commercially available mineral water
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged between 18 and 80 years * Understands and is willing, able and likely to comply with all study procedures and restrictions. * Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow procedures and requirements. * Be able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Women who are breast-feeding * Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes. Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Participation in another study (clinical or cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit, previous participation in this study. * Recent history (within the last year) of alcohol or other substance abuse * An employee of the sponsor or the study site or members of their immediate family. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate * Any participant who, in the judgement of the investigator, should not participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Baseline and Day 8 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Baseline, Day 1, 4, and 10 | 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 |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at one center at United Kingdom.
Pre-assignment details
A total of 26 participants were screened, out of which 24 participants were randomized to the study and 2 participants withdrawn their consent.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were included for baseline evaluation. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 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
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 41.4 Years STANDARD_DEVIATION 13.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 24 |
| other Total, other adverse events | 2 / 23 | 4 / 22 | 3 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
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
Time frame: Baseline and Day 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Post-dose (Post Baseline) | 3.43 Score on a scale | Standard Deviation 0.76 |
| Test Product | 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 |
| Test Product | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Change | -0.95 Score on a scale | Standard Deviation 0.925 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Post-dose (Post Baseline) | 3.42 Score on a scale | Standard Deviation 0.754 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Pre-dose (Baseline) | 4.32 Score on a scale | Standard Deviation 0.518 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Change | -0.90 Score on a scale | Standard Deviation 0.933 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Pre-dose (Baseline) | 4.36 Score on a scale | Standard Deviation 0.398 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Change | -0.83 Score on a scale | Standard Deviation 0.849 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Post-dose (Post Baseline) | 3.53 Score on a scale | Standard Deviation 0.865 |
p-value: 0.551295% CI: [-0.46, 0.25]Mixed Models Analysis
p-value: 0.967195% CI: [-0.36, 0.35]Mixed Models Analysis
p-value: 0.58395% CI: [-0.46, 0.26]Mixed Models Analysis
Secondary
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
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
Time frame: Baseline, Day 1, 4, and 10
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 0.91 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 0.41 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Pre-dose (Baseline) | 4.30 Score on a scale | Standard Deviation 0.466 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Post-dose (Post Baseline) | 3.60 Score on a scale | Standard Deviation 0.843 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 1: Pre-dose (Baseline) | 4.38 Score on a scale | Standard Deviation 0.364 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 1: Post-dose (Post Baseline) | 4.13 Score on a scale | Standard Deviation 0.769 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 1: Change from Baseline | -0.26 Score on a scale | Standard Deviation 0.748 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Change from Baseline | -0.70 Score on a scale | Standard Deviation 0.875 |
| Reference Product | 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 0.418 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 10: Post-dose (Post Baseline) | 3.49 Score on a scale | Standard Deviation 0.841 |
| Reference Product | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 10: Change from Baseline | -0.82 Score on a scale | Standard Deviation 0.827 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 1: Post-dose (Post Baseline) | 3.86 Score on a scale | Standard Deviation 0.961 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Post-dose (Post Baseline) | 3.98 Score on a scale | Standard Deviation 0.762 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 10: Pre-dose (Baseline) | 4.36 Score on a scale | Standard Deviation 0.428 |
| Negative Control | 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 0.486 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 10: Change from Baseline | -0.62 Score on a scale | Standard Deviation 0.958 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Pre-dose (Baseline) | 4.23 Score on a scale | Standard Deviation 0.404 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 1: Change from Baseline | -0.44 Score on a scale | Standard Deviation 0.876 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 10: Post-dose (Post Baseline) | 3.74 Score on a scale | Standard Deviation 0.862 |
| Negative Control | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Day 4: Change from Baseline | -0.25 Score on a scale | Standard Deviation 0.827 |