A study to investigate the effect of a sensitivity toothpaste in providing relief from tooth sensitivity
- Conditions
- Tooth sensitivityOral Health
- Registration Number
- ISRCTN16831120
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare
- Brief Summary
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31381157 (added 07/04/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
2. Aged 18-65 years.
3. Good general and mental health with, in the opinion of the investigator or medically qualified designee:
3.1. No clinically significant and relevant abnormalities of medical history or oral examination.
3.2. Absence of any condition that would impact on the subject’s safety or well-being or affect the individual’s 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. Dental health:
At Visit 1 (Screening):
5.1. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
5.2. Minimum of 20 natural teeth.
5.3. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
5.3.1. Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
5.3.2. Tooth with MGI score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical mobility of =1
5.3.3. Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
At Visit 2, Baseline (Pre-treatment):
5.4. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:
5.4.1. Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple = 20g) and evaporative air assessment (Schiff sensitivity score = 2)
Note: All teeth which meet the EAR, MGI and mobility inclusion criteria and none of the dentition exclusion criteria at Screening should be assessed by tactile stimulus at Visit 2. Those teeth which meet the required tactile threshold (Yeaple = 20g) should then be assessed by evaporative air stimulus. The examiner will select two Test Teeth from those which meet both the tactile threshold and Schiff sensitivity score criteria. Test Teeth should not be adjacent to each other and preferably in different quadrants.
1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast-feeding
3. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
4. Clinical study/experimental product:
4.1. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
4.2. Previous participation in this study
5. Recent history (within the last year) of alcohol or other substance abuse
6. An employee of the sponsor or the study site or members of their immediate family
The site for this protocol is the Clinical trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials unit are eligible to participate
7. Disease
7.1.Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes
7.2. Any condition which, in the opinion of the investigator, causes xerostomia
8. General dentition exclusions:
8.1. Dental prophylaxis within 4 weeks of screening.
8.2. Tongue or lip piercing or presence of dental implants.
8.3. Desensitizing treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).
8.4. Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of screening
8.5. Teeth bleaching within 8 weeks of screening
9. Specific dentition exclusions for test teeth:
9.1. Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening
9.2. 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
9.3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
10. Product use:
10.1. Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (subjects will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
10.2. Use of a sensitivity toothpaste for instant relief of tooth sensitivity within two weeks of screening.
11. Concomitant medication:
11.1. 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, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs
11.2. Currently taking antibiotics or has taken antibioti
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in teeth sensitivity, assessed using the Schiff sensitivity score measured at baseline and again at day 3
- Secondary Outcome Measures
Name Time Method Change in threshold of tactile sensitivity, measured using a a Yeaple probe at baseline and again at day 3