Dentin HypersensitivityPhase 2NCT03943095
Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity
A Phase 2 study testing Potassium Nitrate and Stannous Fluoride in people with Dentin Hypersensitivity and Dentin Sensitivity, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Dentin Sensitivity
- What is being tested?
- Potassium Nitrate and Stannous Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2019to 28 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements
- Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
- AT VISIT 1 (Screening): Participant must have
- a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years
Show all 14Show fewer
- a minimum of 20 natural teeth
- a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically diagnosed DH; each tooth must meet the following criteria:
- exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)
- Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin) only
- Clinical mobility less than or equal to (=<) 1
- DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity (tactile threshold [=<] 20 gram (g); Schiff sensitivity score greater than or equal to [>=] 2)
- AT VISIT 2 (Baseline):
- Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile and evaporative air sensitivity (each tooth must have a tactile threshold (=<) 20 g and a Schiff sensitivity score (>=) 2) at the Screening and Baseline visits
Who cannot join
- Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
- Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
- Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
- Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
- Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test [UPT] at Screening)
- Participant who is a breast-feeding female
Show all 33Show fewer
- Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participant with a recent history (within the last year) of alcohol or other substance abuse
- Participant who has participated in another tooth desensitizing treatment study within 8 weeks Screening
- Participant who has used an oral care product indicated for the relief of DH within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
- Participant who has had dental prophylaxis within 4 weeks of Screening
- Participant who has had a tooth bleaching procedure within 8 weeks of Screening
- Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening
- Participant who has had scaling or root planning within 3 months of Screening
- Participant with gross periodontal disease
- Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy
- Participant with a tongue or lip piercing or presence of multiple dental implants
- Participant with fixed or removable partial dentures
- Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer
- SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':
- Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening
- Tooth with exposed dentin but with deep, defective or facial restorations
- Tooth with full crown or veneer
- Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentin
- Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with the perception of pain (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs)
- AT VISIT 1 (Screening):
- Participant who has taken antibiotics in the 2 weeks prior to the Screening visit
- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatization period
- Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia
- Participant who requires antibiotic prophylaxis for dental procedures
- Participant who has previously been enrolled in this study
- Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.
Read the detailed description
This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.
- Conditions
- Dentin Hypersensitivity, Dentin Sensitivity
- Being tested
- Potassium Nitrate, Stannous Fluoride
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium NitrateOther
The test dentifrice contains 5% w/w potassium nitrate.
Stannous FluorideOther
The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 5 % weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing. Receives: Other: Potassium Nitrate; Other: Stannous Fluoride |
| Control Dentifrice | Active comparator | Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing. Receives: Other: Stannous Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Baseline (Day 0)
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 3
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 7
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 14
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 28
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 56
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Baseline (Day 0)
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 3
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 7
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 14
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 28
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 56
Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Baseline (Day 0)
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Day 3
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Day 7
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Day 14
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Day 28
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Measured: Day 56
Secondary outcomes (2)
Change From Baseline in Schiff Sensitivity Score at Day 56
Evaporative air sensitivity was assessed on the facial surfaces of teeth by directing one second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from a distance of approximately 1 cm. Participant response to stimulus was evaluated using Schiff sensitivity scale following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3;a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline are derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable.
Measured: Baseline (Day 0), Day 56
Change From Baseline (Day 0) in Tactile Threshold on Day 56
Tactile sensitivity was assessed for eligible teeth using constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until tactile threshold for that visit is reached. The probe tip was placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant was asked whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gives two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20g;at all subsequent visits,80g.If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (Baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline are derived from ANCOVA model which included treatment as factor and baseline tactile senstivity as covariate with change from baseline as dependent variable.
Measured: Baseline (Day 0), Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start13 May 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943095
- Sponsor's protocol ID
- 209723
- Other IDs
- 209723
- Status last verified
- Aug 2020
- First submitted
- 7 May 2019
- Last updated
- 11 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT03943095
- Acronym / sponsor ID
- 209723
- Conditions
- Dentin Hypersensitivity, Dentin Sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 11 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.
Detailed description
This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Other: Potassium Nitrate, Other: Stannous FluorideParticipants will be instructed to apply a strip of dentifrice (a full brush head) containing 5 % weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million [ppm] fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing. |
| Control Dentifrice | Active comparator | Other: Stannous FluorideParticipants will be instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements
- Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
- AT VISIT 1 (Screening): Participant must have
Key exclusion criteria (33 listed)
- Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
- Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
- Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
- Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
- Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test [UPT] at Screening)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium NitrateThe test dentifrice contains 5% w/w potassium nitrate. | Other | Test Dentifrice |
| Stannous FluorideThe test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride). | Other | Control Dentifrice, Test Dentifrice |
Primary outcome
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Time frame: Baseline (Day 0)
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Time frame: Day 3
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7
Time frame: Day 7
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Time frame: Day 14
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Time frame: Day 28
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Time frame: Day 56
Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Time frame: Baseline (Day 0)
Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Time frame: Day 3
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7
Time frame: Day 7
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Time frame: Day 14
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Time frame: Day 28
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Time frame: Day 56
Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Time frame: Baseline (Day 0)
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Time frame: Day 3
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
Time frame: Day 7
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Time frame: Day 14
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Time frame: Day 28
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Time frame: Day 56
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
2 secondary outcomes
Change From Baseline in Schiff Sensitivity Score at Day 56
Time frame: Baseline (Day 0), Day 56
Change From Baseline (Day 0) in Tactile Threshold on Day 56
Time frame: Baseline (Day 0), Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Potassium Nitrate and Stannous Fluoride in people with Dentin Hypersensitivity and Dentin Sensitivity, run by GlaxoSmithKline at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) (time frame: Baseline (Day 0)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.