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CompletedNCT05459558Updated Apr 12, 2024Results posted

Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks

An interventional study of Experimental Dentifrice 1 and Experimental Dentifrice 2 in Oral Hygiene, sponsored by HALEON. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by HALEON · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.

Read the detailed description

This will be a single-center, 8-week, randomized, controlled, single-blind, three treatment-arm, parallel design, stratified clinical study in healthy volunteers with a propensity to form dental stain. It has been designed to investigate changes in tooth stain and color, following twice-daily use of two experimental dentifrices, after four and eight weeks twice daily use; a regular fluoride dentifrice will be included as reference dentifrice. Sufficient participants will be screened to randomize approximately 300 participants to study treatment to ensure approximately 270 participants complete the study.

02

Conditions studied

  • Oral Hygiene

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03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 280 is above the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

HALEON is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle 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 with generally good oral health with:

    1. At least 16 natural (vital) teeth including 11 of the 12 anterior teeth.
    2. Facial surfaces of all anterior teeth (maxillary and mandibular) and lingual surfaces of anterior teeth (mandibular only) gradable for MLSI with no significant calculus or large restorations as judged by the clinical examiner.
    3. Presence of extrinsic dental stain (formed on the surface of the teeth) as determined from a gross visual examination which, in the opinion of the clinical examiner, originates from the diet and/or use of tobacco products.
    4. Facial surfaces of central and lateral maxillary incisors gradable for tooth shade (free of cervical margin defects and restorations which could impact assessment), as judged by the clinical examiner.
    5. Baseline Total MLSI (Area x Intensity) greater than or equal to (>=)15 for the facial surfaces of the 12 anterior teeth.
    6. Baseline mean tooth shade (VITA Bleachedguide 3D-MASTER) >=11 on the facial surfaces of the 4 maxillary incisors.

Exclusion criteria

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 an employee of the sponsor 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 30 days of study entry and/or during study participation or who has previously been enrolled in this study.
  • 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 study 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 during the study.
  • Participant who is breastfeeding.
  • Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
  • Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or lifestyle restrictions of the study.
  • Participant with a recent history (within the last year) of alcohol or other substance abuse.
  • Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling.

  • Participant using daily oral care products and/or taking daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with study outcomes, specifically:

    1. currently daily use of mouthwashes containing ingredients known to cause tooth stain (for example, chlorhexidine or cetylpyridinium chloride),
    2. past or current use of minocycline,
    3. use of tetracycline or doxycycline within 30 days of screening and/or during the study,
    4. medications known to cause tooth stain (for example, drugs or supplements containing metal ions known to increase enamel staining).
  • Participant who has used any professionally-dispensed tooth whitening products 6 months prior to baseline or any over-the-counter products (including peroxide- or covarine blue-containing dentifrice, but not other daily use whitening dentifrices) 3 months prior to baseline.

  • Specific exclusions for assessment teeth:

    1. Non-vital tooth.
    2. Tooth with evidence of current or recent carious lesions.
    3. Tooth used as an abutment for fixed or partial dentures.
    4. Tooth adjacent to fixed retainers and fixed or removable orthodontic appliances.
    5. Tooth with surface irregularities, cracked enamel, discoloration due to trauma or orthodontic treatment, tetracycline stain, restorations or hyper-/hypoplastic areas, which, in the opinion of the clinical examiner, grading of extrinsic dental stain and tooth shade.
    6. Tooth with a crown or veneer.
    7. Tooth with exposed dentine which, in the opinion of the investigator, could impact grading of extrinsic dental stain and tooth shade.

  • General oral exclusions:

    1. Generalized severe gingivitis or advanced periodontal disease; treatment of periodontal disease (including surgery) within 12 months of screening; scaling or root planning within 3 months of screening.
    2. Any oral condition requiring immediate care.
    3. Having received a dental prophylaxis within 8 weeks of screening.
  • Participant who, in the opinion of the investigator, should not participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
280 participants (actual)

Study arms

  • Experimental
    Experimental Dentifrice 1

    Randomized participants will brush their teeth with the experimental dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

    Drug: Experimental Dentifrice 1

  • Experimental
    Experimental Dentifrice 2

    Randomized participants will brush their teeth with the experimental dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

    Drug: Experimental Dentifrice 2

  • Active comparator
    Reference Dentifrice

    Randomized participants will brush their teeth with the Reference dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

    Drug: Reference Dentifrice

Interventions

  • DrugExperimental Dentifrice 1

    5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).

  • DrugExperimental Dentifrice 2

    5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.

  • DrugReference Dentifrice

    Regular Fluoride Dentifrice.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8

    Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 8 value.

    Time frame: Baseline and Week 8

Secondary outcomes

  1. Change From Baseline in Mean Total MLSI Score at Week 4

    Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 4 value.

    Time frame: Baseline and Week 4

  2. Change From Baseline in Mean Total MLSI Score at Weeks 4 and 8

    Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

    Time frame: Baseline, Week 4 and Week 8

  3. Change From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8

    Tooth shade (color) of the facial surfaces of the four central and lateral maxillary incisors was assessed by a trained clinical examiner using the VITA Bleached guide 3D-MASTER. It used 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 Bleached guide, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

    Time frame: Baseline, Week 4 and Week 8

  4. Change From Baseline in Mean Total MLSI Score in Gingival Sites, Interproximal Sites and Body Sites at Weeks 4 and 8

    Extrinsic dental stain area and its intensity were assessed at the specific tooth sites (Gingival site: Crescent-shaped band, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. Body Site: The remainder of the tooth surface). MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain was scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third area and light intensity stain, 2= Stain covering up to two thirds area and moderate intensity stain, 3= Stain covering more than two thirds area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score= Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

    Time frame: Baseline, Week 4 and Week 8

  5. Change From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8

    Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. Thus, MLSI score for both Area and Intensity ranged from 0 to 3, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

    Time frame: Baseline, Week 4 and Week 8

07

Results

Posted Apr 12, 2024

Participant flow

The study was conducted at a single center in the United States of America.

Participant flow — Overall Study
MilestoneExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Started939294
Completed929189
Not completed115
Withdrew: Adverse event100
Withdrew: Scheduling issue013
Withdrew: Withdrawal by subject002

Outcome measures

PrimaryChange From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8

Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 8 value.

Time frame:
Baseline and Week 8
Reported as:
Mean · score on a scale
Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8-2.33 ± 0.048-2.42 ± 0.049-0.38 ± 0.049
Statistical analysis
  • Experimental Dentifrice 1 · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.)
  • Experimental Dentifrice 2 · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.)
SecondaryChange From Baseline in Mean Total MLSI Score at Week 4

Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 4 value.

Time frame:
Baseline and Week 4
Reported as:
Mean · score on a scale
Change From Baseline in Mean Total MLSI Score at Week 4
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Change From Baseline in Mean Total MLSI Score at Week 4-1.94 ± 0.046-1.93 ± 0.046-0.19 ± 0.047
Statistical analysis
  • Experimental Dentifrice 1 · Mixed Models with Repeated Measures · p = <0.0001
  • Experimental Dentifrice 2 · Mixed Model with Repeated Measures · p = <0.0001
SecondaryChange From Baseline in Mean Total MLSI Score at Weeks 4 and 8

Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

Time frame:
Baseline, Week 4 and Week 8
Reported as:
Mean · score on a scale
Change From Baseline in Mean Total MLSI Score at Weeks 4 and 8
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Week 4-1.94 ± 0.046-1.93 ± 0.046-0.19 ± 0.047
Week 8-2.33 ± 0.048-2.42 ± 0.049-0.38 ± 0.049
Statistical analysis
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -1.75 · 95% CI -1.88 to -1.62
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -1.74 · 95% CI -1.87 to -1.61
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.) · Mean difference (final values): -1.95 · 95% CI -2.08 to -1.81
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.) · Mean difference (final values): -2.04 · 95% CI -2.18 to -1.90
SecondaryChange From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8

Tooth shade (color) of the facial surfaces of the four central and lateral maxillary incisors was assessed by a trained clinical examiner using the VITA Bleached guide 3D-MASTER. It used 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 Bleached guide, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

Time frame:
Baseline, Week 4 and Week 8
Reported as:
Mean · score on a scale
Change From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Week 4-0.81 ± 0.068-0.59 ± 0.0680.01 ± 0.069
Week 8-1.73 ± 0.134-1.85 ± 0.134-0.04 ± 0.136
Statistical analysis
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.81 · 95% CI -1.00 to -0.62
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.60 · 95% CI -0.79 to -0.41
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.) · Mean difference (final values): -1.68 · 95% CI -2.06 to -1.31
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 (p-value adjusted for multiplicity using Graphical Approach.) · Mean difference (final values): -1.81 · 95% CI -2.19 to -1.44
SecondaryChange From Baseline in Mean Total MLSI Score in Gingival Sites, Interproximal Sites and Body Sites at Weeks 4 and 8

Extrinsic dental stain area and its intensity were assessed at the specific tooth sites (Gingival site: Crescent-shaped band, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. Body Site: The remainder of the tooth surface). MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain was scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third area and light intensity stain, 2= Stain covering up to two thirds area and moderate intensity stain, 3= Stain covering more than two thirds area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score= Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

Time frame:
Baseline, Week 4 and Week 8
Reported as:
Mean · score on a scale
Change From Baseline in Mean Total MLSI Score in Gingival Sites, Interproximal Sites and Body Sites at Weeks 4 and 8
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Gingival Sites, Week 4-2.39 ± 0.064-2.40 ± 0.065-0.17 ± 0.065
Gingival Sites, Week 8-2.96 ± 0.067-3.09 ± 0.067-0.46 ± 0.068
Interproximal Sites, Week 4-2.27 ± 0.055-2.25 ± 0.056-0.20 ± 0.056
Interproximal Sites, Week 8-2.69 ± 0.057-2.81 ± 0.057-0.40 ± 0.058
Body Sites, Week 4-0.82 ± 0.046-0.84 ± 0.047-0.20 ± 0.047
Body Sites, Week 8-0.95 ± 0.043-0.96 ± 0.043-0.26 ± 0.043
Statistical analysis
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.23 · 95% CI -2.41 to -2.05
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.23 · 95% CI -2.41 to -2.05
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.50 · 95% CI -2.69 to -2.31
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.63 · 95% CI -2.81 to -2.44
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.06 · 95% CI -2.22 to -1.91
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.04 · 95% CI -2.20 to -1.89
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.29 · 95% CI -2.45 to -2.13
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -2.41 · 95% CI -2.57 to -2.25
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.63 · 95% CI -0.76 to -0.50
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.64 · 95% CI -0.77 to -0.51
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.69 · 95% CI -0.81 to -0.57
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.69 · 95% CI -0.81 to -0.57
SecondaryChange From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8

Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, 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. Thus, MLSI score for both Area and Intensity ranged from 0 to 3, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.

Time frame:
Baseline, Week 4 and Week 8
Reported as:
Mean · score on a scale
Change From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8
score on a scaleExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
Area, Week 4-0.98 ± 0.028-0.96 ± 0.028-0.09 ± 0.028
Area, Week 8-1.24 ± 0.026-1.30 ± 0.026-0.16 ± 0.026
Intensity, Week 4-0.96 ± 0.023-0.96 ± 0.023-0.09 ± 0.023
Intensity, Week 8-1.16 ± 0.024-1.21 ± 0.025-0.19 ± 0.025
Statistical analysis
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.89 · 95% CI -0.97 to -0.82
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.87 · 95% CI -0.95 to -0.79
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -1.08 · 95% CI -1.15 to -1.01
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -1.15 · 95% CI -1.22 to -1.07
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.87 · 95% CI -0.93 to -0.80
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.87 · 95% CI -0.93 to -0.80
  • Experimental Dentifrice 1 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -0.97 · 95% CI -1.04 to -0.90
  • Experimental Dentifrice 2 vs Reference Dentifrice · Mixed Model with Repeated Measures · p = <0.0001 · Mean difference (final values): -1.02 · 95% CI -1.08 to -0.95

Adverse events

Collected over From screening (visit 1) until 5 days following last administration of the study product or last procedure (for approximately 64 days).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Dentifrice 10/93 (0%)0/93 (0%)6/93 (6.5%)
Experimental Dentifrice 20/92 (0%)0/92 (0%)8/92 (8.7%)
Reference Dentifrice0/94 (0%)0/94 (0%)2/94 (2.1%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventExperimental Dentifrice 1Experimental Dentifrice 2Reference Dentifrice
ANGULAR CHEILITISGastrointestinal disorders0/931/920/94
CHAPPED LIPSGastrointestinal disorders0/931/920/94
LIP DRYGastrointestinal disorders0/931/920/94
LIP EXFOLIATIONGastrointestinal disorders0/931/920/94
LIP PAINGastrointestinal disorders0/931/920/94
LIP ULCERATIONGastrointestinal disorders0/931/920/94
ORAL MUCOSAL EXFOLIATIONGastrointestinal disorders0/931/920/94
HEADACHENervous system disorders1/931/921/94
ANXIETYPsychiatric disorders0/931/920/94
ERYTHEMASkin and subcutaneous tissue disorders0/931/920/94

Baseline characteristics

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 post baseline efficacy assessment.

Age, Continuous
Age, Continuous(years)Experimental Dentifrice 1Experimental Dentifrice 2Reference DentifriceTotal
Mean43.4 ± 13.9239.5 ± 13.7340.5 ± 13.9841.2 ± 13.92
Sex: Female, Male
Sex: Female, Male(Participants)Experimental Dentifrice 1Experimental Dentifrice 2Reference DentifriceTotal
Female525059161
Male404131112
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental Dentifrice 1Experimental Dentifrice 2Reference DentifriceTotal
Hispanic or Latino1071027
Not Hispanic or Latino828480246
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Experimental Dentifrice 1Experimental Dentifrice 2Reference DentifriceTotal
African American/African Heritage75618
Asian - Central/South Asian Heritage2136
Asian - East Asian Heritage1113
White - Arabic/North African Heritage1113
White - White/Caucasian/European Heritage818379243
08

Study locations

1 site
  • All Sum Research Center (c/o Family & Cosmetic Dentistry)
    Melbourne, Florida 32940, United States
09

References and documents

Study documents

  • Study protocol · Sep 7, 2022
  • Statistical analysis plan · Oct 4, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05459558
Lead sponsor
HALEON
Responsible party
Sponsor
First posted
Jul 15, 2022
Start date
Sep 15, 2022
Primary completion
Dec 4, 2022
Completion
Dec 4, 2022
Results posted
Apr 12, 2024
Last update
Apr 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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