Phase 4
N=90
A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT06608368 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study — 33.8; 41.6; 36.9; 31.1 millimeter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Test Dentifrice (Sensodyne Repair and Protect Original Mint) (Drug); Positive Control Dentifrice (Sensodyne Fresh Mint) (Drug); Reference Dentifrice (Crest Cavity Protection Regular) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study |
33.8; 41.6; 36.9; 31.1; 36.9; 36.5 | — |
| PRIMARY Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity |
28.1; 38.8; 32.6; 26.5; 34.1; 33.0 | — |
| PRIMARY LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration |
18.8; 26.4; 24.4; 18.0; 23.0; 24.6 | — |
| PRIMARY LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability |
20.7; 21.9; 19.9; 19.4; 20.9; 21.0 | — |
| PRIMARY LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description |
28.8; 36.4; 35.2; 27.4; 32.2; 34.6 | — |
| PRIMARY Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study |
3.5; 3.9; 4.1; 3.2; 3.4; 4.1 | — |
| PRIMARY Number of Participants With a Tooth Sensitivity-free Day Through the Study |
16; 12; 15; 16; 12; 15 | — |
| PRIMARY Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity |
0; 0; 0 | — |
| SECONDARY Mean VAS Score During Tooth Bleaching |
39.0423; 32.8316; 35.7939 | 0.1332 |
| SECONDARY Mean LMS Score During Tooth Bleaching |
31.4069; 26.6679; 31.1071; 25.2392; 22.5202; 26.2188 | 0.1650 |
| SECONDARY Mean Bothersomeness NRS Score During Tooth Bleaching |
3.9603; 3.3288; 3.9735 | 0.0756 |
| SECONDARY Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching |
17.0; 19.0; 17.7 | — |
| SECONDARY Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching |
0; 0; 0 | — |
| SECONDARY Mean VAS Score Post Completion of Tooth Bleaching |
25.0948; 19.0720; 28.4576 | 0.3142 |
| SECONDARY Mean LMS Score Post Completion of Tooth Bleaching |
17.8845; 16.9250; 20.5072; 17.4989; 15.0944; 19.2415 | 0.8417 |
| SECONDARY Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching |
2.9902; 2.7262; 3.2306 | 0.5551 |
| SECONDARY Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching |
32.4; 41.3; 41.0 | — |
| SECONDARY Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching |
0; 0; 0 | — |
| SECONDARY Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score |
-3.3043; -3.6640; -3.2813 | 0.3984 |
Summary
The aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent (%) NovaMin (Calcium Sodium Phosphosilicate) to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5% potassium nitrate (KNO3) and a marketed regular fluoride-containing dentifrice.
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 is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.
- Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
- Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact the participant's safety, 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.
- Participant who wishes and is able to undergo at-home peroxide tooth bleaching.
- Participant with generally good oral health that fulfil all of the following:
- Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
- At least a total of 11 of the facial surfaces of maxillary and mandibular anterior 6 teeth (tooth numbers 6-11 and 22-27) suitable for peroxide whitening and gradable for VITA Bleachedguide evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact tooth bleaching performance or study evaluations as judged by the clinical examiner.
- A minimum of 16 natural teeth.
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 Haleon 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 60 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 or 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 who is pregnant or intending to become pregnant over the duration of the study or who is breastfeeding.
- Participant with known or suspected intolerance or hypersensitivity to the study materials [including the peroxide whitening gel] (or closely related compounds) or any of their stated ingredients.
- Participant who, in the opinion of the investigator or medically qualified designee, has a condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.
- Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
- Participant with a recent history (within the last year) of alcohol or other substance abuse.
- Participant with gross periodontal disease or who has had treatment for periodontal disease (including surgery) within 12 months of Screening or who has had scaling or root planning within 3 months of Screening.
- Participant who has had a tooth bleaching procedure (either professionally dispensed or at home) within 12 months of Screening.
- Participant with a fixed or removable partial prosthesis, multiple dental implants or orthodontic braces/bands or fixed retainer or togue/lip piercing which, in the opi
Data sourced from ClinicalTrials.gov (NCT06608368). 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.