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Dentin SensitivityNCT02752958

Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health

A study testing stannous fluoride in people with Dentin Sensitivity, run by GlaxoSmithKline at 2 sites 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 multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Dentin Sensitivity
What is being tested?
stannous fluoride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesUnited Kingdom
Study dates
23 May 2016to 3 Feb 2017
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy ofthe informed consent form
  • Aged 18-55 years
  • Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination and absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
  • Understands and is willing, able and likely to comply with all study procedures and restrictions
  • At Visit 1 (Screening): Self-reported his of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years, minimum of 20 natural teeth, Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).Tooth with MGI score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical mobility of ≤1 Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
  • At Visit 2 (Baseline): Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: with signs of sensitivity, measured by a qualifying evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Who cannot join

  • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
  • Women who are breast-feeding
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
  • and previous participation in this study
  • Recent history (within the last year) of alcohol or other substance abuse
Show all 12Show fewer
  • An employee of the sponsor or the study site or members of their immediate family
  • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes and any condition which, in the opinion of the investigator, causes xerostomia
  • Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants, desensitizing treatment within 8 weeks of Screening (professional sensitivity, treatments and non-dentifrice sensitivity treatments), gross periodontal disease, treatment of periodontal disease (including surgery)within 12 months of Screening, scaling or root planning within 3 months of Screening and teeth bleaching within 8 weeks of Screening
  • 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, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine and Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
  • Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
  • Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, anti-depressants, mood-altering and anti-inflammatory drugs, currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • GSK Investigational Site

    Ellesmere Port, Cheshire, CH65 4BW

  • GSK Investigational Site

    Widnes, Cheshire, WA8 6PG

Other trials in United Kingdom

About this study

Official title: Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity With a Daily Use Anti-Sensitivity Toothpaste

This multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Changes in oral health related quality of life will be monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Read the detailed description

This will be multicenter, non-comparative design to monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers, using the DHEQ. Changes in DH will be monitored clinically over the 24 week treatment period.

Being tested
stannous 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.

  • stannous fluorideDrug

    0.454% w/w (weight per weight) stannous fluoride

Study groups in NCT02752958
Study groupRoleWhat they receive
stannous fluorideExperimentalThis was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Receives: Drug: stannous fluoride

What is being measured

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

  1. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 4

  2. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 8

  3. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 12

  4. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 16

  5. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 20

  6. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24

    All participants scored first 34 questions present in section 2 of the DHEQ 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. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

    Measured: At Baseline and Week 24

  7. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 4

  8. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 8

  9. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 12

  10. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 16

  11. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 20

  12. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

    Measured: At Baseline and Week 24

  13. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 4

  14. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 8

  15. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 12

  16. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 16

  17. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 20

  18. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ 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. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

    Measured: At Baseline and Week 24

  19. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 4

  20. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 8

  21. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 12

  22. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 16

  23. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 20

  24. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ 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. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

    Measured: At Baseline and Week 24

  25. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 4

  26. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 8

  27. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 12

  28. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 16

  29. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 20

  30. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ 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. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

    Measured: At Baseline and Week 24

  31. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 4

  32. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 8

  33. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 12

  34. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 16

  35. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 20

  36. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ 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. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

    Measured: At Baseline and Week 24

  37. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 4

  38. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 8

  39. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 12

  40. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 16

  41. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 20

  42. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

    Measured: At Baseline and Week 24

  43. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 4

  44. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 8

  45. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12

    : All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 12

  46. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 16

  47. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 20

  48. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

    Measured: At Baseline and Week 24

  49. Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 4

  50. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 8

  51. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 12

  52. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 16

  53. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 20

  54. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 24

  55. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 4

  56. Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 8

  57. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life.

    Measured: At Baseline and Week 12

  58. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 16

  59. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 20

  60. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 24

  61. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 4

  62. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 8

  63. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 12

  64. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 16

  65. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 20

  66. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

    Measured: At Baseline and Week 24

Timeline

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

  1. First posted27 Apr 2016 (estimated)
  2. Study start23 May 2016
  3. Primary completion1 Feb 2017
  4. Study completion3 Feb 2017

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752958
Sponsor's protocol ID
204930
Status last verified
Jun 2018
First submitted
25 Apr 2016
Last updated
27 Aug 2018
Data monitoring committee
No

Publications

  • Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.

    PubMed 31640741

Questions about this trial

What is this clinical trial studying?

A study testing stannous fluoride in people with Dentin Sensitivity, run by GlaxoSmithKline at 2 sites 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 6 inclusion and 12 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 27 Aug 2018). 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?

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4 (time frame: At Baseline and Week 4). The study lists 66 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 NCT02752958, which also lists 1 linked publication.

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 27 Aug 2018.

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