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NCT06150573

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

Completed NA Results posted Last updated 24 July 2025
What this trial tests

NA trial testing Test Dentifrice in Dentin Sensitivity in 160 participants. Completed in 18 July 2024.

Timeline
27 November 2023
Primary endpoint
18 July 2024
18 July 2024

Quick facts

Lead sponsorHALEON
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment160
Start date27 November 2023
Primary completion18 July 2024
Estimated completion18 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

HALEON — full company profile →

Who can join

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 Bleaching Primary · 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.

GroupValue95% CI
Test Dentifrice12.00± 0.355
Reference Dentifrice12.06± 0.348
Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching Secondary · 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.

GroupValue95% CI
Test Dentifrice12.08± 0.353
Reference Dentifrice11.71± 0.346
Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching Secondary · 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
GroupValue95% CI
Test Dentifrice0.69± 0.044
Reference Dentifrice0.87± 0.043
Week 24
GroupValue95% CI
Test Dentifrice0.72± 0.053
Reference Dentifrice1.03± 0.052
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites Secondary · 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
GroupValue95% CI
Test Dentifrice0.02± 0.012
Reference Dentifrice0.03± 0.011
Mean Gingival MLSI, Week 24
GroupValue95% CI
Test Dentifrice0.01± 0.014
Reference Dentifrice0.05± 0.014
Mean Interproximal MLSI, Week 12
GroupValue95% CI
Test Dentifrice1.37± 0.088
Reference Dentifrice1.71± 0.086
Mean Interproximal MLSI, Week 24
GroupValue95% CI
Test Dentifrice1.44± 0.105
Reference Dentifrice2.04± 0.103
Mean Body MLSI, Week 12
GroupValue95% CI
Test Dentifrice0.00± 0.007
Reference Dentifrice0.01± 0.007
Mean Body MLSI, Week 24
GroupValue95% CI
Test Dentifrice0.00± 0.005
Reference Dentifrice0.01± 0.004
Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching Secondary · 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
GroupValue95% CI
Test Dentifrice0.55± 0.025
Reference Dentifrice0.69± 0.024
Week 24
GroupValue95% CI
Test Dentifrice0.57± 0.027
Reference Dentifrice0.74± 0.027
Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching Secondary · 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
GroupValue95% CI
Test Dentifrice0.46± 0.023
Reference Dentifrice0.52± 0.023
Week 24
GroupValue95% CI
Test Dentifrice0.48± 0.027
Reference Dentifrice0.60± 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.

Test Dentifrice
Serious: 1/79 (1%)
Deaths: 0/79
Reference Dentifrice
Serious: 1/81 (1%)
Deaths: 0/81

Serious adverse events (2 terms)

ReactionSystemTest DentifriceReference Dentifrice
PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders
TRANSIENT ISCHAEMIC ATTACKNervous system disorders
Other adverse events (16 terms — click to expand)

ReactionSystemTest DentifriceReference Dentifrice
GINGIVAL PAINGastrointestinal disorders
TRAUMATIC ULCERInjury, poisoning and procedural complications
HYPERAESTHESIA TEETHGastrointestinal disorders
ORAL MUCOSAL EXFOLIATIONGastrointestinal disorders
ANGULAR CHEILITISGastrointestinal disorders
CHRONIC CHEEK BITINGGastrointestinal disorders
GINGIVAL DISCOMFORTGastrointestinal disorders
LIP DRYGastrointestinal disorders
NAUSEAGastrointestinal disorders
NONINFECTIVE GINGIVITISGastrointestinal disorders
ORAL DISCOMFORTGastrointestinal disorders
GINGIVAL INJURYInjury, poisoning and procedural complications
OROPHARYNGEAL PAINRespiratory, thoracic and mediastinal disorders
SINUSITISInfections and infestations
DEEP VEIN THROMBOSISVascular disorders
HYPERTENSIONVascular disorders

Most-reported serious reactions: PULMONARY EMBOLISM, TRANSIENT ISCHAEMIC ATTACK.

Data from ClinicalTrials.gov NCT06150573 adverse events section.

Sponsor's own description

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):

  1. A Randomized Clinical Study Investigating the Stain Removal Efficacy of Two Experimental Dentifrices.
    Parkinson CR, Burnett GR, Smith G, Pradhan M, et al · · 2025 · cited 1× · PMID 39806931 · DOI 10.1111/jerd.13373

Verify or expand the search:

Other trials of Test Dentifrice

Trials testing the same drug.

Other recruiting trials for Dentin Sensitivity

Currently open trials in the same condition.

Other HALEON trials

Trials by the same sponsor.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing