N/A
N=160
A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching
Dentin Sensitivity · Oral Hygiene
Bottom Line
View on ClinicalTrials.gov: NCT06150573 ↗Enrolled (actual)
160
Serious AEs
1.3%
Results posted
Jul 2025
Primary outcome: Primary: Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching — 12.00; 12.06 score on a scale — p=0.9141
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Dentifrice (Drug); Reference Dentifrice (Aquafresh Cavity Protection) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching |
12.00; 12.06 | 0.9141 |
| SECONDARY Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching |
12.08; 11.71 | 0.4583 |
| SECONDARY Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching |
0.69; 0.87; 0.72; 1.03 | 0.0042 sig |
| SECONDARY Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites |
0.02; 0.03; 0.01; 0.05; 1.37; 1.71 | 0.2478 |
| SECONDARY Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching |
0.55; 0.69; 0.57; 0.74 | <0.0001 sig |
| SECONDARY Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching |
0.46; 0.52; 0.48; 0.60 | 0.0400 sig |
Summary
The main aim of this study is to investigate the ability of an experimental dentifrice containing 5 percent (%) potassium nitrate (KNO3), 1% alumina and 5% sodium tripolyphosphate (STP), to maintain tooth color and reduce extrinsic dental stain accumulation following peroxide tooth bleaching compared to a regular fluoride 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 is willing and able to undergo at-home tooth bleaching with peroxide containing treatment unsupervised.
- Participant with generally good oral health that fulfil all of the following:
- Teeth suitable for peroxide bleaching and gradable for tooth color and suitable for MLSI evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact peroxide tooth bleaching performance or study evaluations as judged by the clinical examiner.
- Facial surfaces of maxillary anterior 6 teeth (tooth numbers 6-11) [Universal tooth number system] with mean Vita Bleached guide shade greater than or equal to (>=)13 at Visits 1 and 2.
- Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
- Having 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 (self-reported) 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 bleaching treatment] (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 peroxide tooth bleaching procedure (either professionally dispensed or at-home [including peroxide-contain
Data sourced from ClinicalTrials.gov (NCT06150573). 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.