Oral health and tooth sensitivity Oral Health Oral health and tooth sensitivity
Conditions
Interventions
Participants will be recruited and attend a screening appointment to determine eligibility. All eligible participants will be provided with the toothbrush, toothpaste and timing instructions for the a
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent given 2. Aged 18 to 65 years 3. Good general and mental health in the opinion of the investigator or medically qualified designee a. No clinically significant and relevant abnormalities of medical history or oral examination b. No condition that would impact on safety, wellbeing or ability to understand and follow study procedures and requirements 4. Understands and is willing, able and likely to comply with all study procedures and restrictions 5. Minimum of 20 natural teeth 6. 2 sensitive teeth as defined by Schiff scores 2/3 to evaporative stimuli 7. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that have signs of sensitivity, measured by qualifying tactile stimulus (Yeaple = 20g) and evaporative air assessment (Schiff sensitivity score = 2)
Exclusion criteria
Exclusion criteria: 1. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 2. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit 3. Previous participation in this study 4. Recent history (within the last year) of alcohol or other substance abuse 5. An employee of the sponsor or members of their immediate family 6. An employee of the site for this protocol (the Bristol Dental School and Hospital) and associated with the Clinical Trials unit 6. Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. 7. Any condition which, in the opinion of the investigator, causes xerostomia 8. Dental prophylaxis within 4 weeks of screening 9. Tongue or lip piercing 10. Desensitizing treatment within 2 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments) 11. Active periodontal disease 12. Teeth bleaching within 8 weeks of screening 13. Teeth with exposed dentine but used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel 14. Teeth with evidence of caries 15. Daily prescription of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Including but not limited to: analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, anti-depressants, and mood-altering and anti-inflammatory drugs. 16. Any subject who, in the judgment of the investigator, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tooth sensitivity assessed by Schiff sensitivity scale score elicited by an evaporative (air) stimulus at baseline and 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tooth tactile sensitivity assessed by tactile sensitivity score elicited by a Yeaple probe stimulus at baseline and 4 days. 2. Tooth sensitivity after immediate use assessed by Schiff sensitivity scale score elicited by an evaporative (air) stimulus and tactile sensitivity score elicited by a Yeaple probe stimulus at baseline and 60 s. 3. Long term tooth sensitivity assessed by Schiff sensitivity scale score elicited by an evaporative (air) stimulus and tactile sensitivity score elicited by a Yeaple probe stimulus at baseline and 2 weeks. 4. Dentin hypersensitivity relief assessed by visual analogue scale (VAS) at baseline, 60 s, 4 days and 2 weeks 5. Plaque assessed by quantitative light-induced fluorescence-digital (QLF-D) at baseline, 4 days and 2 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed