Adults 18 to 65, any sex, with Dentin Sensitivity or Oral Hygiene. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adjusted Mean VITA Shade Score at 24 Weeks After Tooth BleachingPrimary· At Week 24 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.
Group
Value
95% CI
Test Dentifrice
12.00
± 0.355
Reference Dentifrice
12.06
± 0.348
Adjusted Mean VITA Shade Score at 12 Weeks After Tooth BleachingSecondary· At Week 12 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.
Group
Value
95% CI
Test Dentifrice
12.08
± 0.353
Reference Dentifrice
11.71
± 0.346
Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth BleachingSecondary· At Week 12 and Week 24 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
Week 12
Group
Value
95% CI
Test Dentifrice
0.69
± 0.044
Reference Dentifrice
0.87
± 0.043
Week 24
Group
Value
95% CI
Test Dentifrice
0.72
± 0.053
Reference Dentifrice
1.03
± 0.052
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body SitesSecondary· At Week 12 and Week 24 after tooth bleaching
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 pre
Mean Gingival MLSI, Week 12
Group
Value
95% CI
Test Dentifrice
0.02
± 0.012
Reference Dentifrice
0.03
± 0.011
Mean Gingival MLSI, Week 24
Group
Value
95% CI
Test Dentifrice
0.01
± 0.014
Reference Dentifrice
0.05
± 0.014
Mean Interproximal MLSI, Week 12
Group
Value
95% CI
Test Dentifrice
1.37
± 0.088
Reference Dentifrice
1.71
± 0.086
Mean Interproximal MLSI, Week 24
Group
Value
95% CI
Test Dentifrice
1.44
± 0.105
Reference Dentifrice
2.04
± 0.103
Mean Body MLSI, Week 12
Group
Value
95% CI
Test Dentifrice
0.00
± 0.007
Reference Dentifrice
0.01
± 0.007
Mean Body MLSI, Week 24
Group
Value
95% CI
Test Dentifrice
0.00
± 0.005
Reference Dentifrice
0.01
± 0.004
Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth BleachingSecondary· At Week 12 and Week 24 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.
Week 12
Group
Value
95% CI
Test Dentifrice
0.55
± 0.025
Reference Dentifrice
0.69
± 0.024
Week 24
Group
Value
95% CI
Test Dentifrice
0.57
± 0.027
Reference Dentifrice
0.74
± 0.027
Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth BleachingSecondary· At Week 12 and Week 24 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.
Week 12
Group
Value
95% CI
Test Dentifrice
0.46
± 0.023
Reference Dentifrice
0.52
± 0.023
Week 24
Group
Value
95% CI
Test Dentifrice
0.48
± 0.027
Reference Dentifrice
0.60
± 0.026
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· NA
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NCT07317128 — Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HALEON
Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06150573.