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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.
This will be a randomized, single-blind, single-center, controlled, two arm, stratified (clinically diagnosed dentine hypersensitivity [DH] [Yes/No]), parallel group study to evaluate the efficacy of an experimental dentifrice containing 5% KNO3, 1% alumina and 5% STP, to maintain tooth color and reduce the accumulation of extrinsic tooth stain following peroxide tooth bleaching compared to a regular fluoride-containing dentifrice. The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 160 participants to study treatment to ensure approximately 128 evaluable participants complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Dentifrice | Experimental | Participants will dose the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 parts per million [ppm] fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days. |
|
| Reference Dentifrice | Active Comparator | Participants will dose the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Dentifrice | Drug | Dentifrice containing 5% weight by weight (w/w) KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicated improvement. | At Week 24 after tooth bleaching |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicated improvement. |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silverstone Research Group | Las Vegas | Nevada | 89146 | United States |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
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A total of 178 participants were screened into the study, 160 participants were enrolled and randomized to treatment (79 participants in the test dentifrice group and 81 participants in the reference dentifrice group). A total of 154 randomized participants completed the study.
This study was conducted at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Dentifrice | Participants dosed the toothbrush provided with a strip of test dentifrice (5 percent [%] Potassium nitrate [KNO3], 1% alumina, 5% Sodium tripolyphosphate [STP] and 1150 parts per million [ppm] fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
| FG001 | Reference Dentifrice | Participants dosed the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety population comprised all randomized participants who received at least one dose of the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Dentifrice | Participants dosed the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicated improvement. | The modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one assessment of tooth color after the bleaching period. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 24 after tooth bleaching |
|
From signing of informed consent form until 5 days after the last administration of the study product or the last study procedure (up to approximately 195 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A serious adverse event (SAE) is a particular category of AE where the adverse outcome is serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Dentifrice | Participants dosed the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GINGIVAL PAIN | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2023 | Jul 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2024 | Jul 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Reference Dentifrice (Aquafresh Cavity Protection) | Drug | Dentifrice containing 1150 ppm fluoride as sodium fluoride. |
|
| At Week 12 after tooth bleaching |
| Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean total score was presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement. | At Week 12 and Week 24 after tooth bleaching |
| Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. The facial surface of each assessable tooth was divided into individual sites. The gingival site was defined as a crescent-shaped band, approximately 2 millimeters wide, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The remainder of the tooth surface was called as body site. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean score was presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement. | At Week 12 and Week 24 after tooth bleaching |
| Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=area with no stain, 1=Stain covering up to one third of area, 2=Stain covering up to two thirds of area, 3=Stain covering more than two thirds of area. Total score ranged from 0 to 3, where lower score indicated improvement. | At Week 12 and Week 24 after tooth bleaching |
| Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Intensity (I) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=no stain, 1=light intensity stain, 2=moderate intensity stain, 3=heavy intensity stain. Total score ranged from 0 to 3, where lower score indicated improvement. | At Week 12 and Week 24 after tooth bleaching |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | Reference Dentifrice | Participants dosed the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants dosed the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days.
| OG001 | Reference Dentifrice | Participants dosed the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. |
|
|
|
| Secondary | Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicated improvement. | The mITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 12 after tooth bleaching |
|
|
|
|
| Secondary | Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean total score was presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement. | The mITT population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 12 and Week 24 after tooth bleaching |
|
|
|
|
| Secondary | Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. The facial surface of each assessable tooth was divided into individual sites. The gingival site was defined as a crescent-shaped band, approximately 2 millimeters wide, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The remainder of the tooth surface was called as body site. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean score was presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement. | The mITT population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 12 and Week 24 after tooth bleaching |
|
|
|
|
| Secondary | Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=area with no stain, 1=Stain covering up to one third of area, 2=Stain covering up to two thirds of area, 3=Stain covering more than two thirds of area. Total score ranged from 0 to 3, where lower score indicated improvement. | The mITT population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 12 and Week 24 after tooth bleaching |
|
|
|
|
| Secondary | Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Intensity (I) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=no stain, 1=light intensity stain, 2=moderate intensity stain, 3=heavy intensity stain. Total score ranged from 0 to 3, where lower score indicated improvement. | The mITT population. Only those participants with data available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | At Week 12 and Week 24 after tooth bleaching |
|
|
|
|
| 0 |
| 79 |
| 1 |
| 79 |
| 39 |
| 79 |
| EG001 | Reference Dentifrice | Participants dosed the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and brushed for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice was used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants performed the first application of peroxide tooth bleaching as per the instructions provided and continued the application daily for up to 7 days. | 0 | 81 | 1 | 81 | 42 | 81 |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | Systematic Assessment |
|
| HYPERAESTHESIA TEETH | Gastrointestinal disorders | Systematic Assessment |
|
| ORAL MUCOSAL EXFOLIATION | Gastrointestinal disorders | Systematic Assessment |
|
| ANGULAR CHEILITIS | Gastrointestinal disorders | Systematic Assessment |
|
| CHRONIC CHEEK BITING | Gastrointestinal disorders | Systematic Assessment |
|
| GINGIVAL DISCOMFORT | Gastrointestinal disorders | Systematic Assessment |
|
| LIP DRY | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| NONINFECTIVE GINGIVITIS | Gastrointestinal disorders | Systematic Assessment |
|
| ORAL DISCOMFORT | Gastrointestinal disorders | Systematic Assessment |
|
| TRAUMATIC ULCER | Injury, poisoning and procedural complications | Systematic Assessment |
|
| GINGIVAL INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Systematic Assessment |
|
HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Week 24 |
|
|
| <0.0001 |
| Adjusted Mean Difference |
| -0.31 |
| Standard Error of the Mean |
| 0.074 |
| 2-Sided |
| 95 |
| -0.46 |
| -0.17 |
| Superiority |
| Mean Gingival MLSI, Week 24 |
|
|
| Mean Interproximal MLSI, Week 12 |
|
|
| Mean Interproximal MLSI, Week 24 |
|
|
| Mean Body MLSI, Week 12 |
|
|
| Mean Body MLSI, Week 24 |
|
|
| ANOVA |
| 0.0957 |
| Adjusted Mean Difference |
| -0.03 |
| Standard Error of the Mean |
| 0.020 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.01 |
| Superiority |
| Mean Interproximal MLSI, Week 12 | ANOVA | 0.0063 | Adjusted Mean Difference | -0.34 | Standard Error of the Mean | 0.122 | 2-Sided | 95 | -0.58 | -0.10 | Superiority |
| Mean Interproximal MLSI, Week 24 | ANOVA | <0.0001 | Adjusted Mean Difference | -0.60 | Standard Error of the Mean | 0.147 | 2-Sided | 95 | -0.89 | -0.31 | Superiority |
| Mean Body MLSI, Week 12 | ANOVA | 0.1536 | Adjusted Mean Difference | -0.01 | Standard Error of the Mean | 0.010 | 2-Sided | 95 | -0.03 | 0.01 | Superiority |
| Mean Body MLSI, Week 24 | ANOVA | 0.1166 | Adjusted Mean Difference | -0.01 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | -0.02 | 0.00 | Superiority |
| Week 24 |
|
|
| <0.0001 |
| Adjusted Mean Difference |
| -0.18 |
| Standard Error of the Mean |
| 0.038 |
| 2-Sided |
| 95 |
| -0.25 |
| -0.10 |
| Superiority |
| Week 24 |
|
|
| 0.0010 |
| Adjusted Mean Difference |
| -0.12 |
| Standard Error of the Mean |
| 0.037 |
| 2-Sided |
| 95 |
| -0.20 |
| -0.05 |
| Superiority |