Dentin SensitivityNCT05750745
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
A study testing Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect in people with Dentin Sensitivity, run by HALEON at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
- 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).
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- Good general oral health, with a minimum of 20 natural teeth.
- 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:
- Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
- Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only
- Clinical mobility = 0.
- 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:
- Tactile threshold <= 20 g at Screening and Baseline
- Schiff sensitivity score >= 2 at Screening and Baseline.
- 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:
- Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2 or Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3.
Who cannot join
- 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).
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- 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.
- Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood altering and anti-inflammatory drugs.
- 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:
- Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1).
- Tooth with exposed dentin but with deep, defective or facial restorations.
- Tooth with full crown or veneer.
- Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes.
- Sensitive tooth with contributing aetiologies other than erosion, abrasion or recession to exposed dentine.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Preventive Dentistry, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200011
About this study
Official title: A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
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.
- Conditions
- Dentin Sensitivity
- Being tested
- Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime, Sensodyne Repair and Protect
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensodyne Sensitivity & GumDrug
Sensodyne Sensitivity \& Gum toothpaste is containing 0.454% w/w SnF2.
Crest Cavity Protection Fresh LimeDrug
Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).
Sensodyne Repair and ProtectDrug
Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | 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. Receives: Drug: Sensodyne Sensitivity & Gum |
| Negative Control | Active comparator | 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. Receives: Drug: Crest Cavity Protection Fresh Lime |
| Positive Control | Active comparator | 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. Receives: Drug: Sensodyne Repair and Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (8)
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 6
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.
Measured: Baseline and Week 6
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.
Measured: Baseline and Week 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.
Measured: Baseline, Week 6 and Week 12
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.
Measured: Baseline, Week 6 and Week 12
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.
Measured: Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start8 May 2023
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750745
- Sponsor's protocol ID
- 300026
- Status last verified
- Sep 2024
- First submitted
- 20 Feb 2023
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
- ClinicalTrials.gov ID
- NCT05750745
- Acronym / sponsor ID
- 300026
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Drug: Sensodyne Sensitivity & GumParticipants 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. |
| Negative Control | Active comparator | Drug: Crest Cavity Protection Fresh LimeParticipants 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. |
| Positive Control | Active comparator | Drug: Sensodyne Repair and ProtectParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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):
Key exclusion criteria (39 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensodyne Sensitivity & GumSensodyne Sensitivity \& Gum toothpaste is containing 0.454% w/w SnF2. | Drug | Test Dentifrice |
| Crest Cavity Protection Fresh LimeCrest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF). | Drug | Negative Control |
| Sensodyne Repair and ProtectSensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS). | Drug | Positive Control |
Primary outcome
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)
Time frame: Baseline and Week 12
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.
8 secondary outcomes
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)
Time frame: Baseline and Week 12
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)
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Time frame: Baseline and Week 6
Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Time frame: Baseline and Week 6
Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)
Time frame: Baseline and Week 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)
Time frame: Baseline, Week 6 and Week 12
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)
Time frame: Baseline, Week 6 and Week 12
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)
Time frame: Baseline, Week 6 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime and Sensodyne Repair and Protect in people with Dentin Sensitivity, run by HALEON at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.