Phase 2
N=104
Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity
Dentin Hypersensitivity · Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT03943095 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) — 2.61; 2.60 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Potassium Nitrate (Other); Stannous Fluoride (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) |
2.61; 2.60 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3 |
1.19; 1.46 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7 |
0.73; 1.20 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14 |
0.52; 1.07 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28 |
0.32; 0.75 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56 |
0.12; 0.42 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0) |
11.06; 12.31 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3 |
31.35; 27.98 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7 |
47.45; 38.75 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14 |
60.59; 48.53 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28 |
71.67; 57.94 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56 |
79.71; 64.80 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline) |
3.1; 3.2 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3 |
3.6; 3.6 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7 |
2.2; 3.2 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14 |
1.7; 2.8 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28 |
1.0; 2.1 | — |
| PRIMARY Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56 |
0.5; 1.3 | — |
| SECONDARY Change From Baseline in Schiff Sensitivity Score at Day 56 |
-2.48; -2.17 | — |
| SECONDARY Change From Baseline (Day 0) in Tactile Threshold on Day 56 |
69.34; 51.94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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 (= =] 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 (= =) 2) at the Screening and Baseline visits
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03943095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.