Dentin SensitivityNCT05243745

Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

A study testing 3% PVM/MA + 5% KNO3 Combination, 3% PVM/MA only and 5% KNO3 Only in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Sensitivity
What is being tested?: 3% PVM/MA + 5% KNO3 Combination, 3% PVM/MA only and 5% KNO3 Only
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited Kingdom
Study dates: 28 Feb 2022to 3 Oct 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of a signed and dated informed consent indicating 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 comply with scheduled visits, product usage requirements and other study procedures.
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, that would impact the participant's safety or 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.
Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
AT VISIT 1 (Screening):
Participant must have

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a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years.
a minimum of 20 natural teeth.
a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH; each tooth must meet the following criteria:
exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986)
clinical mobility = 0 (Laster et al., 1975)
Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 gram (g); Schiff sensitivity score greater than or equal to >= 2).
AT VISIT 2 (Baseline):
Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre molars) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 g; Schiff sensitivity score >= 2) at the Screening and Baseline visits.
Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2).
The examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline. Test teeth should not be adjacent to each other and preferably in different quadrants.

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 GlaxoSmithKline Consumer Healthcare (GSK CH) employee 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.
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.
Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
Female 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).

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Participant who is unwilling or unable to comply with the Lifestyle Considerations.
Participant with a recent history (within the last year) of alcohol or other substance abuse.
Participant who has participated in another tooth sensitivity study within 8 weeks of Screening.
Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
Participant who has had dental prophylaxis within 4 weeks of Screening.
Participant who has had a teeth bleaching procedure within 8 weeks of Screening.
Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening.
Participant who has had scaling or root planning within 3 months of Screening.
Participant with gross periodontal disease.
Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
Participant with a tongue or lip piercing.
Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator, would impact study outcomes.
Participant with multiple dental implants which, in the opinion of the investigator, would impact study outcomes.
Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':
Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening.
Tooth with exposed dentine 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, would impact study outcomes.
Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine.
Sensitive tooth not expected to benefit from use of a sensitivity toothpaste in the opinion of the investigator
Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, antidepressants, mood-altering and anti-inflammatory drugs).
AT VISIT 1 (Screening):
Participant who has taken antibiotics in the 2 weeks prior to the Screening visit.
AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatisation period.
Participant who is 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.
Participant who has previously been enrolled in this study.
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.

United Kingdom1 site

Bristol Dental School, University of Bristol
Bristol, BS1 2LY

Other trials in United Kingdom

About this study

Official title: An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensitivity

This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.

Read the detailed description

This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth) clinical study in healthy participants with sensitive teeth.

Conditions: Dentin Sensitivity
Being tested: 3% PVM/MA + 5% KNO3 Combination, 3% PVM/MA only, 5% KNO3 Only, Regular Fluoride
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3% PVM/MA + 5% KNO3 CombinationOther
Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.
3% PVM/MA onlyOther
Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.
5% KNO3 OnlyOther
Toothpastes containing 5% KNO3 only will be used as comparator 2 product.
Regular FluorideOther
Toothpaste containing regular fluoride will be used as negative control.

Study groups in NCT05243745
Study group	Role	What they receive
Test Product	Experimental	Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product is a combination toothpaste of 3% methyl vinyl ether/maleic anhydride co-polymer (PVM/MA) + 5% Potassium Nitrate (KNO3). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); Participants will be permitted to rinse with water post-brushing. Receives: Other: 3% PVM/MA + 5% KNO3 Combination
Comparator 1	Active comparator	Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 toothpaste is containing 3% PVM/MA. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing. Receives: Other: 3% PVM/MA only
Comparator 2	Active comparator	Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 toothpaste is containing 5% KNO3. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing. Receives: Other: 5% KNO3 Only
Negative Control	Other	Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control is regular fluoride toothpaste. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing. Receives: Other: Regular Fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter(mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Measured: Baseline (Day 0)
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Measured: Day 3
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Measured: Day 14
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Measured: Day 28
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Measured: Day 56
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (grams [g]). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Baseline (Day 0)
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 3
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 14
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 28
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Measured: Day 56
Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0)
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Measured: Baseline (Day 0)
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Measured: Day 3
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Measured: Day 14
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Measured: Day 28
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Measured: Day 56

Secondary outcomes (11)

Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56
Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 mm coronal to gingival margin from approximately 1 cm. Participant response to stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3;0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated an improvement.
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56
Tactile sensitivity was assessed for 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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A positive change from Baseline indicated an improvement.
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56
The DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of two sections. Section 1 included 9 questions about participant's sensitive teeth and the impact it has on participant's everyday life. All participants scored question number 7 to 9. Question (Q)7 (On a scale of 1 to 10 how intense are the sensations) was scored from 1=not at all intense to 10=worst imaginable; Q8 (On a scale of 1 to 10 how bothered are you by any sensations?) was scored from 1=not at all bothered to 10=extremely bothered; Q9 (On a scale of 1 to 10 how well you can tolerate the sensations?) was scored from 1=can easily tolerate to 10=can't tolerate at all. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated an improvement (less impact of tooth sensitivity on participant's everyday life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Section 2 included 15 questions about the ways in which sensations in participant's teeth affected them in their daily life. Questions were grouped into the following domains: Restrictions(Q1-3), Adaptation(Q4-6), Social Impact(Q7-9), Emotional Impact(Q10-12), and Identity(Q13-15). All participants scored 15 questions using a 7-point scale, where 7=Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score was derived from the sum of scores in single domains and ranged from 15 to 105. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Restriction domain(Q1 to 3) of Section 2 consisted of following questions: Q1:Having sensation in my teeth takes a lot of the pleasure out of eating and drinking; Q2:It takes a long time to finish some foods and drinks because of sensations in my teeth; Q3:There have been times when I have had problems eating ice cream because of these sensations. All participants scored Q1 to 3 using a 7-point scale, where 7=Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement(less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28, 56
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Adaptation domain (Q4 to 6) of Section 2 consisted of following questions: Q4: I have to change the way I eat or drink certain things; Q5: I have to be careful how I breathe on a cold day; Q6: When eating some foods, I have made sure they don't touch certain teeth. All participants scored Q4 to 6 using a 7-point scale, where 7= Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Social Impact domain(Q7 to 9) of Section 2 consisted of following questions: Q7:Because of sensations I take longer than others to finish meal; Q8:I have to be careful what I eat when I am with others because of sensation in my teeth; Q9:Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. All participants scored Q7 to 9 using a 7-point scale, where 7=Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement(less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Emotional Impact domain (Q10 to 12) of Section 2 consisted of following questions: Q10: I have been anxious that something I eat, or drink might cause sensations in my teeth; Q11: The sensations in my teeth have been irritating; Q12: The sensations in my teeth have been annoying. All participants scored Q10 to 12 using a 7-point scale, where 7= Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56
DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Identity domain (Q13 to 15) of Section 2 consisted of following questions: Q13: Having these sensations in my teeth makes me feel old; Q14: Having these sensations in my teeth makes me feel damaged; Q15: Having these sensations in my teeth makes me feel as though I am unhealthy. All participants scored Q13 to 15 using a 7-point scale, where 7= Strongly agree, 6=Agree, 5=Agree a little, 4=neither agree or disagree, 3=disagree a little, 2=disagree, and 1=strongly disagree. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56
The NRS was a segmented numeric version of the visual analog scale (VAS) in which a participant selected a number from 0 to 10 that best reflected the intensity of the discomfort caused by sensitivity in their teeth, where 0=no discomfort and 10=worst discomfort imaginable. Lower score indicated less discomfort caused by the sensitivity.
Measured: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56
The NRS was a segmented numeric version of the VAS in which a participant selected a number from 0 to 10 that best reflected the intensity of the discomfort caused by sensitivity in their teeth, where 0=no discomfort and 10=worst discomfort imaginable. Lower score indicated less discomfort caused by the sensitivity. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (reduction in discomfort caused by sensitivity).
Measured: Baseline (Day 0), Days 3, 14, 28 and 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20223 Oct 2022

First posted17 Feb 2022
Study start28 Feb 2022
Primary completion3 Oct 2022
Study completion3 Oct 2022

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: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05243745
Sponsor's protocol ID: 218220
Status last verified: May 2024
First submitted: 8 Feb 2022
Last updated: 20 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity

All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensitivity
ClinicalTrials.gov ID: NCT05243745
Acronym / sponsor ID: 218220
Conditions: Dentin Sensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 28 Feb 2022 (actual)
Primary completion: 3 Oct 2022 (actual)
Study completion: 3 Oct 2022 (actual)
First posted: 17 Feb 2022 (actual)
Results: Posted 20 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Test Product	Experimental	Other: 3% PVM/MA + 5% KNO3 CombinationParticipants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product is a combination toothpaste of 3% methyl vinyl ether/maleic anhydride co-polymer (PVM/MA) + 5% Potassium Nitrate (KNO3). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); Participants will be permitted to rinse with water post-brushing.
Comparator 1	Active comparator	Other: 3% PVM/MA onlyParticipants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 toothpaste is containing 3% PVM/MA. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.
Comparator 2	Active comparator	Other: 5% KNO3 OnlyParticipants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 toothpaste is containing 5% KNO3. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.
Negative Control	Other	Other: Regular FluorideParticipants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control is regular fluoride toothpaste. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Provision of a signed and dated informed consent indicating 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 comply with scheduled visits, product usage requirements and other study procedures.
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, that would impact the participant's safety or 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.
Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
AT VISIT 1 (Screening):

Key exclusion criteria (35 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 GlaxoSmithKline Consumer Healthcare (GSK CH) employee 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.
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.
Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
Female participant who is breastfeeding.

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
3% PVM/MA + 5% KNO3 CombinationToothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.	Other	Test Product
3% PVM/MA onlyToothpaste containing 3% PVM/MA only will be used as comparator 1 product.	Other	Comparator 1
5% KNO3 OnlyToothpastes containing 5% KNO3 only will be used as comparator 2 product.	Other	Comparator 2
Regular FluorideToothpaste containing regular fluoride will be used as negative control.	Other	Negative Control

Primary outcome

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Time frame: Baseline (Day 0)
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter(mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Time frame: Day 3
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Time frame: Day 14
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Time frame: Day 28
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Time frame: Day 56
Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Time frame: Baseline (Day 0)
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (grams [g]). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Time frame: Day 3
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Time frame: Day 14
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Time frame: Day 28
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Time frame: Day 56
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 at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0)
Time frame: Baseline (Day 0)
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Time frame: Day 3
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Time frame: Day 14
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Time frame: Day 28
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Time frame: Day 56
Sensitive teeth were defined as teeth with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 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). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

11 secondary outcomes

Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28, 56
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56
Time frame: Baseline (Day 0), Days 3, 14, 28 and 56

Results and safety

Results posted to the registry on 20 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	29	29
Comparator 1	31	31
Comparator 2	31	30
Negative Control	29	28

Primary outcome: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)

Time frame: Baseline (Day 0). Mean (Standard Deviation). Unit: score on a scale

Measure	Test Product n = 29	Comparator 1 n = 31	Comparator 2 n = 31	Negative Control n = 29
Value	2.43 (0.438)	2.44 (0.442)	2.44 (0.442)	2.34 (0.356)

Population analysed: 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 clinical performance assessment (Schiff sensitivity assessment or Tactile sensitivity assessment).

Primary outcome: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3

Time frame: Day 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Test Product n = 29	Comparator 1 n = 28	Comparator 2 n = 29	Negative Control n = 28
Value	1.31 (0.618)	1.41 (0.681)	1.88 (0.456)	2.09 (0.431)

Population analysed: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Primary outcome: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14

Time frame: Day 14. Mean (Standard Deviation). Unit: score on a scale

Measure	Test Product n = 27	Comparator 1 n = 29	Comparator 2 n = 30	Negative Control n = 29
Value	0.69 (0.419)	1.00 (0.567)	1.37 (0.414)	2.10 (0.387)

Population analysed: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Primary outcome: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28

Time frame: Day 28. Mean (Standard Deviation). Unit: score on a scale

Measure	Test Product n = 25	Comparator 1 n = 30	Comparator 2 n = 30	Negative Control n = 26
Value	0.52 (0.510)	0.92 (0.588)	1.13 (0.414)	2.10 (0.375)

Population analysed: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 5 days after last use of study product (up to approximately 61 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Comparator 1	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Comparator 2	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Negative Control	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Dentin Sensitivity

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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 3% PVM/MA + 5% KNO3 Combination, 3% PVM/MA only and 5% KNO3 Only in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.

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 17 inclusion and 35 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 Sep 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 United Kingdom. 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 Sep 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?

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) (time frame: Baseline (Day 0)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243745.

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 Sep 2024.