CClinicalTrials.gg
Sign In
CompletedNCT05750745Updated Nov 20, 2024Results posted

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

An interventional study of Sensodyne Sensitivity & Gum and Crest Cavity Protection Fresh Lime in Dentin Sensitivity, sponsored by HALEON. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by HALEON · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Read the detailed description

This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.

02

Conditions studied

  • Dentin Sensitivity
03

In context

Dentin Sensitivity

283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 416 is above the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity 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 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 study procedures are performed.
  • Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures.
  • A participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • Participant who owns a smartphone with the WeChat application installed.

  • A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):

    1. Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire).
    2. Good general oral health, with a minimum of 20 natural teeth.
    3. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH.

  • Each eligible tooth must meet all of the following criteria:

    1. Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
    2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only
    3. Clinical mobility = 0.
    4. DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to [\<=] 20 g and Schiff sensitivity score more than or equal to [>=] 2).
  • A participant who presents the following oral and dental inclusions will apply at Baseline (Visit 2):
  • All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be reassessed for tactile sensitivity first; eligible teeth with Baseline tactile threshold \<= 20g will then be re-assessed for evaporative (air) sensitivity.

  • Participants must have a minimum of two non-adjacent, accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity:

    1. Tactile threshold \<= 20 g at Screening and Baseline
    2. Schiff sensitivity score >= 2 at Screening and Baseline.
    3. VAS >= 40 mm at Baseline.
  • The clinical examiner will select two 'test teeth' from those eligible teeth which meet the tactile threshold and Schiff sensitivity score criteria at both Screening and Baseline, and the VAS criterion at Baseline.

  • Each test tooth must demonstrate a consistent DH response to the evaporative (air) stimulus at both Screening and Baseline:

    1. Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2 or Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3.

Exclusion criteria

Exclusion Criteria:

  • Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
  • Participant who has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1).
  • Participant who is participating in, has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
  • Participant who is using, or has used, an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1). Participant will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims.
  • Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1).
  • Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1).
  • Participant who seen to rinse with water while brushing with the acclimatization toothpaste during review of their brushing compliance videos at Baseline (Visit 2).
  • 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 unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.
  • Female participant who is pregnant or intending to become pregnant during the study (self-reported).
  • Female participant who is breastfeeding.
  • Participant with a recent history (within the last year) of alcohol and/or substance abuse.
  • 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 taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain.

    1. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood altering and anti-inflammatory drugs.
    2. Examples of herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions.
  • Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
  • Participant who requires antibiotic prophylaxis for dental procedures.
  • At Screening (Visit 1): participant who has taken antibiotics within 2 weeks of their Screening visit.
  • At Baseline (Visit 2): participant who has taken antibiotics within 2 weeks of their Baseline visit (during the acclimatisation period).
  • Participant who has had a professional or self-applied tooth bleaching procedure within 8 weeks of Screening (Visit 1).
  • Participant who has had dental prophylaxis within 4 weeks of Screening (Visit 1).
  • Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).
  • Participant who has had scaling or root planning within 3 months of Screening (Visit 1).
  • Participant with a tongue or lip piercing.
  • Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease.
  • Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
  • Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
  • Participant with multiple dental implants which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
  • Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.

  • Participant with specific dentition exclusions for "Test Teeth" are as follows:

    1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1).
    2. Tooth with exposed dentin but with deep, defective or facial restorations.
    3. Tooth with full crown or veneer.
    4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
    5. Sensitive tooth with contributing aetiologies other than erosion, abrasion or recession to exposed dentine.
    6. Sensitive tooth, in the opinion of the investigator or medically qualified designee, not expected to respond to treatment with an anti-sensitivity toothpaste.
  • Participant who has previously been enrolled in this study.
  • Any participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
416 participants (actual)

Study arms

  • Experimental
    Test Dentifrice

    Participants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Sensitivity \& Gum. After brushing, participants will be instructed to rinse once with 10 milliliters (mL) of water using the measuring cup provided.

    Drug: Sensodyne Sensitivity & Gum

  • Active comparator
    Negative Control

    Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Crest Cavity Protection Fresh Lime. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided.

    Drug: Crest Cavity Protection Fresh Lime

  • Active comparator
    Positive Control

    Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Repair and Protect. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided.

    Drug: Sensodyne Repair and Protect

Interventions

  • DrugSensodyne Sensitivity & Gum

    Sensodyne Sensitivity \& Gum toothpaste is containing 0.454% w/w SnF2.

  • DrugCrest Cavity Protection Fresh Lime

    Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).

  • DrugSensodyne Repair and Protect

    Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).

06

What researchers measure

Primary outcomes

  1. Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)

    Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.

    Time frame: Baseline and Week 12

  2. Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

    Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participants then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

    Time frame: Baseline and Week 12

  3. Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

    Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

    Time frame: Baseline and Week 6

  4. Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.

    Time frame: Baseline and Week 6

  5. Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

    Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

    Time frame: Baseline and Week 6

  6. Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

    Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

    Time frame: Baseline, Week 6 and Week 12

  7. Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

    Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement.

    Time frame: Baseline, Week 6 and Week 12

  8. Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

    Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0(Participant did not respond to air stimulation) to 3(Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

    Time frame: Baseline, Week 6 and Week 12

07

Results

Posted Nov 20, 2024

Participant flow

This study was conducted at a single center in China.

Participant flow — Overall Study
MilestoneTest Dentifrice (Sensodyne Sensitivity and Gum)Positive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)
Started975096
Completed954996
Not completed210
Withdrew: Adverse event100
Withdrew: Protocol violation100
Withdrew: Withdrawal by subject010

Outcome measures

PrimaryAdjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

Time frame:
Baseline and Week 12
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)
score on a scaleTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)-0.90 ± 0.068-0.74 ± 0.068
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · Mixed Model with Repeated Measure (MMRM) · p = 0.0871 · Adjusted mean difference: -0.17 · 95% CI -0.36 to 0.02Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.

Time frame:
Baseline and Week 12
Reported as:
Mean · grams
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)
gramsTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)25.86 ± 3.00819.65 ± 2.977
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · van Elteren Test · p = 0.0972 · Adjusted mean difference: 6.21 · 95% CI -0.78 to 13.20Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participants then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

Time frame:
Baseline and Week 12
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)
score on a scaleTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)-38.84 ± 2.872-33.02 ± 2.830
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.0671 · Adjusted mean difference: -5.81 · 95% CI -12.04 to 0.41Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

Time frame:
Baseline and Week 6
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
score on a scaleTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)-0.51 ± 0.049-0.38 ± 0.049
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.0673 · Adjusted mean difference: -0.13 · 95% CI -0.27 to 0.01Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement in sensitivity.

Time frame:
Baseline and Week 6
Reported as:
Mean · grams
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
gramsTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)11.74 ± 2.3939.36 ± 2.357
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · van Elteren Test · p = 0.4050 · Adjusted mean difference: 2.38 · 95% CI -2.44 to 7.20Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0 (Participant did not respond to air stimulation) to 3 (Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

Time frame:
Baseline and Week 6
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
score on a scaleTest Dentifrice (Sensodyne Sensitivity and Gum)Negative Control (Crest Cavity Protection Fresh Lime)
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)-21.92 ± 2.603-16.28 ± 2.556
Statistical analysis
  • Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.0346 · Adjusted mean difference: -5.64 · 95% CI -10.88 to -0.41Adjusted mean difference was calculated as test minus negative control.
SecondaryAdjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

Time frame:
Baseline, Week 6 and Week 12
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
score on a scalePositive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)
Change from Baseline at Week 6-0.36 ± 0.069-0.38 ± 0.049
Change from Baseline at Week 12-0.67 ± 0.095-0.74 ± 0.068
Statistical analysis
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.8256 · Adjusted mean difference: 0.02 · 95% CI -0.15 to 0.19Adjusted mean difference was calculated as positive control minus negative control.
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.5314 · Adjusted mean difference: 0.07 · 95% CI -0.16 to 0.30Adjusted mean difference was calculated as positive control minus negative control.
SecondaryAdjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A positive change from Baseline indicated an improvement.

Time frame:
Baseline, Week 6 and Week 12
Reported as:
Mean · grams
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
gramsPositive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)
Change from Baseline at Week 66.77 ± 2.8839.36 ± 2.357
Change from Baseline at Week 1218.53 ± 3.83019.65 ± 2.977
Statistical analysis
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · van Elteren Test · p = 0.5575 · Adjusted mean difference: -2.59 · 95% CI -8.48 to 3.30Adjusted mean difference was calculated as positive control minus negative control.
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · van Elteren Test · p = 0.7717 · Adjusted mean difference: -1.12 · 95% CI -9.60 to 7.37Adjusted mean difference was calculated as positive control minus negative control.
SecondaryAdjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)

Evaporative (air) sensitivity was assessed on the facial surfaces of the two test teeth selected by the examiner at Baseline by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using Schiff sensitivity scale with scores ranging from 0(Participant did not respond to air stimulation) to 3(Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus). Participant then rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated an improvement in sensitivity.

Time frame:
Baseline, Week 6 and Week 12
Reported as:
Mean · score on a scale
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 and Week 12 (Positive Control vs. Negative Control)
score on a scalePositive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)
Change from Baseline at Week 6-15.53 ± 3.123-16.28 ± 2.556
Change from Baseline at Week 12-29.30 ± 3.542-33.02 ± 2.830
Statistical analysis
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.8180 · Adjusted mean difference: 0.75 · 95% CI -5.63 to 7.12Adjusted mean difference was calculated as positive control minus negative control.
  • Positive Control (Sensodyne Repair and Protect) vs Negative Control (Crest Cavity Protection Fresh Lime) · MMRM · p = 0.3322 · Adjusted mean difference: 3.73 · 95% CI -3.83 to 11.28Adjusted mean difference was calculated as positive control minus negative control.

Adverse events

Collected over From signing of the informed consent form until 5 days following the last administration of the study product or last study procedure (up to approximately 123 days).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Dentifrice (Sensodyne Sensitivity and Gum)0/97 (0%)0/97 (0%)16/97 (16.5%)
Positive Control (Sensodyne Repair and Protect)0/50 (0%)0/50 (0%)9/50 (18%)
Negative Control (Crest Cavity Protection Fresh Lime)0/96 (0%)0/96 (0%)11/96 (11.5%)
Most frequent other events
Showing 10 of 24
Most frequent other events
EventTest Dentifrice (Sensodyne Sensitivity and Gum)Positive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)
MOUTH INJURYInjury, poisoning and procedural complications3/972/501/96
FACE INJURYInjury, poisoning and procedural complications0/972/501/96
MOUTH ULCERATIONGastrointestinal disorders3/970/500/96
LIP ULCERATIONGastrointestinal disorders1/970/502/96
ORAL BLOOD BLISTERGastrointestinal disorders0/970/502/96
ANGULAR CHEILITISGastrointestinal disorders2/970/500/96
GINGIVITISInfections and infestations2/971/500/96
ORAL CAVITY FISTULAGastrointestinal disorders0/971/500/96
ORAL MUCOSAL BLISTERINGGastrointestinal disorders0/971/500/96
GINGIVAL ABSCESSInfections and infestations0/971/501/96

Baseline characteristics

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)Test Dentifrice (Sensodyne Sensitivity and Gum)Positive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)Total
Mean42.4 ± 7.6443.7 ± 7.5543.2 ± 7.5743.0 ± 7.58
Sex: Female, Male
Sex: Female, Male(Participants)Test Dentifrice (Sensodyne Sensitivity and Gum)Positive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)Total
Female894788224
Male62816
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Test Dentifrice (Sensodyne Sensitivity and Gum)Positive Control (Sensodyne Repair and Protect)Negative Control (Crest Cavity Protection Fresh Lime)Total
Asian - East Asian Heritage954996240
08

Study locations

1 site
  • Department of Preventive Dentistry, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, 200011, China
09

References and documents

Study documents

  • Study protocol · Feb 14, 2023
  • Statistical analysis plan · Oct 26, 2023

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 Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05750745
Lead sponsor
HALEON
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
May 8, 2023
Primary completion
Sep 19, 2023
Completion
Sep 19, 2023
Results posted
Nov 20, 2024
Last update
Nov 20, 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 Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

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.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

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

Other studies in this condition

Dentin Sensitivity→

Other studies from this sponsor

HALEON

Start the discussion