Trial Outcomes & Findings for A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching (NCT NCT06150573)

Last Updated: 2025-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

At Week 24 after tooth bleaching

Results posted on

2025-07-24

Participant Flow

This study was conducted at a single center in the United States.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	79	81
Overall Study COMPLETED	75	79
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Did not meet study criteria	1	0
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice n=79 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.	Reference Dentifrice n=81 Participants 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.	Total n=160 Participants Total of all reporting groups
Age, Continuous	42.0 years STANDARD_DEVIATION 11.91 • n=5 Participants	37.6 years STANDARD_DEVIATION 13.04 • n=7 Participants	39.8 years STANDARD_DEVIATION 12.65 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	60 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 24 after tooth bleaching

Population: 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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=75 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.	Reference Dentifrice n=79 Participants 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.
Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching	12.00 score on a scale Standard Error 0.355	12.06 score on a scale Standard Error 0.348

SECONDARY outcome

Timeframe: At Week 12 after tooth bleaching

Population: The mITT population. Only those participants with data available at the specified time point were analyzed.

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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=72 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.	Reference Dentifrice n=77 Participants 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.
Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching	12.08 score on a scale Standard Error 0.353	11.71 score on a scale Standard Error 0.346

SECONDARY outcome

Timeframe: At Week 12 and Week 24 after tooth bleaching

Population: The mITT population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=78 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.	Reference Dentifrice n=81 Participants 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.
Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching Week 12	0.69 score on a scale Standard Error 0.044	0.87 score on a scale Standard Error 0.043
Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching Week 24	0.72 score on a scale Standard Error 0.053	1.03 score on a scale Standard Error 0.052

SECONDARY outcome

Timeframe: At Week 12 and Week 24 after tooth bleaching

Population: The mITT population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=78 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.	Reference Dentifrice n=81 Participants 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.
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Gingival MLSI, Week 12	0.02 score on a scale Standard Error 0.012	0.03 score on a scale Standard Error 0.011
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Gingival MLSI, Week 24	0.01 score on a scale Standard Error 0.014	0.05 score on a scale Standard Error 0.014
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Body MLSI, Week 12	0.00 score on a scale Standard Error 0.007	0.01 score on a scale Standard Error 0.007
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Interproximal MLSI, Week 12	1.37 score on a scale Standard Error 0.088	1.71 score on a scale Standard Error 0.086
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Interproximal MLSI, Week 24	1.44 score on a scale Standard Error 0.105	2.04 score on a scale Standard Error 0.103
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Mean Body MLSI, Week 24	0.00 score on a scale Standard Error 0.005	0.01 score on a scale Standard Error 0.004

SECONDARY outcome

Timeframe: At Week 12 and Week 24 after tooth bleaching

Population: The mITT population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=78 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.	Reference Dentifrice n=81 Participants 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.
Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching Week 12	0.55 score on a scale Standard Error 0.025	0.69 score on a scale Standard Error 0.024
Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching Week 24	0.57 score on a scale Standard Error 0.027	0.74 score on a scale Standard Error 0.027

SECONDARY outcome

Timeframe: At Week 12 and Week 24 after tooth bleaching

Population: The mITT population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=78 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.	Reference Dentifrice n=81 Participants 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.
Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching Week 12	0.46 score on a scale Standard Error 0.023	0.52 score on a scale Standard Error 0.023
Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching Week 24	0.48 score on a scale Standard Error 0.027	0.60 score on a scale Standard Error 0.026

Adverse Events

Test Dentifrice

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Reference Dentifrice

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Dentifrice n=79 participants at risk 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.	Reference Dentifrice n=81 participants at risk 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.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/79 • 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.	1.2% 1/81 • 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.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.3% 1/79 • 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.	0.00% 0/81 • 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.

Other adverse events

Additional Information

Haleon Response Center

HALEON

Phone: +441932959500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER