N/A
N=120
Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT05243745 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) — 2.43; 2.44; 2.44; 2.34 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3% PVM/MA + 5% KNO3 Combination (Other); 3% PVM/MA only (Other); 5% KNO3 Only (Other); Regular Fluoride (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) |
2.43; 2.44; 2.44; 2.34 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3 |
1.31; 1.41; 1.88; 2.09 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14 |
0.69; 1.00; 1.37; 2.10 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28 |
0.52; 0.92; 1.13; 2.10 | — |
| PRIMARY Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56 |
0.33; 0.69; 1.17; 2.02 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0) |
12.76; 11.94; 12.74; 12.24 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3 |
46.38; 40.00; 27.59; 22.14 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14 |
58.15; 48.62; 40.33; 24.83 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28 |
62.60; 51.83; 48.50; 25.38 | — |
| PRIMARY Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56 |
67.93; 58.23; 48.83; 28.57 | — |
| PRIMARY Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0) |
3.79; 3.68; 3.68; 3.24 | — |
| PRIMARY Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3 |
3.48; 3.36; 3.72; 3.25 | — |
| PRIMARY Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14 |
2.59; 3.10; 3.60; 3.24 | — |
| PRIMARY Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28 |
2.24; 2.93; 3.30; 3.27 | — |
| PRIMARY Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56 |
1.72; 2.35; 3.17; 3.25 | — |
| SECONDARY Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 |
2.43; 2.44; 2.44; 2.34; -1.12; -1.04 | 0.4990 |
| SECONDARY Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 |
12.76; 11.94; 12.74; 12.24; 33.62; 27.86 | 0.0231 sig |
| SECONDARY Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 |
5.66; 5.32; 4.77; 4.86; -0.62; 0.04 | — |
| SECONDARY Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 |
67.41; 60.06; 57.19; 61.79; 0.62; -1.71 | — |
| SECONDARY Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 |
15.14; 13.32; 12.03; 13.72; 0.10; -0.50 | — |
| SECONDARY Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 |
14.55; 13.48; 13.26; 13.38; 0.17; -0.93 | — |
| SECONDARY Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 |
11.38; 10.26; 9.74; 10.59; 0.38; -0.04 | — |
| SECONDARY Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 |
14.93; 13.10; 12.45; 13.38; 0.17; -0.04 | — |
| SECONDARY Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 |
11.41; 9.90; 9.71; 10.72; -0.21; -0.21 | — |
| SECONDARY Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 |
5.3; 5.1; 4.6; 4.3; 4.9; 5.0 | — |
| SECONDARY Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 |
5.3; 5.1; 4.6; 4.3; -0.5; -0.1 | — |
Summary
This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.
Eligibility Criteria
Inclusion Criteria
- Provision of a signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any study procedures are performed.
- Participant who is willing and able to comply with scheduled visits, product usage requirements 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 or relevant abnormalities in medical history, or upon oral examination, that would impact the participant's safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
- Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
- AT VISIT 1 (Screening):
Participant must have
- a self-reported history of tooth sensitivity 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 confirmed DH; each tooth must meet the following criteria:
- exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
- MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986)
- clinical mobility = 0 (Laster et al., 1975)
- Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold 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) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to = 2) at the Screening and Baseline visits.
Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2).
The examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline. Test teeth should not be adjacent to each other and preferably in different quadrants.
Exclusion Criteria
- Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study 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 of study entry and/or during study participation.
- Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study 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.
- Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
- Female participant who is breastfeeding.
- Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
- Participant who is unwilling or unable to comply with the Lifestyle Considerations.
- Participant with a recent history (within the
Data sourced from ClinicalTrials.gov (NCT05243745). 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.