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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Other: 3% PVM/MA + 5% KNO3 Combination; Other: 5% KNO3 Only; Other: 3% PVM/MA only; Other: Regular Fluoride

• Registration Number: NCT05243745
• Lead Sponsor: HALEON

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Study Start: 2022-02-28
• Status Verified: 2022-10
• Primary Completion: 2022-10-03
• Study Completion: 2022-10-03
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

1. a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years.

2. a minimum of 20 natural teeth.

3. 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.

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Exclusion Criteria

• Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a 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).

• 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':

  1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening.
  2. Tooth with exposed dentine but with deep, defective or facial restorations.
  3. Tooth with full crown or veneer.
  4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator, would impact study outcomes.
  5. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine.
  6. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Product	3% PVM/MA + 5% KNO3 Combination	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.
Comparator 2	5% KNO3 Only	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.
Comparator 1	3% PVM/MA only	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.
Negative Control	Regular Fluoride	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.

Primary Outcome Measures

Name	Time	Method
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)	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	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	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	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	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)	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	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	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	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	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)	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	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	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	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bristol Dental School, University of Bristol; 🇬🇧 Bristol, United Kingdom