Project Hedwig-study number 218220-V1
Research type
Research Study
Full title
A proof of principle (PoP) study to evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity
IRAS ID
310206
Contact name
Nicola X West
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare (GSK CH)
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
GlaxoSmithKline Consumer Healthcare (GSK CH) has developed a new combination toothpaste containing 2 ingredients with different modes of action to help protect teeth from dentine hypersensitivity. Toothpastes containing each of these ingredients on their own have been shown to help with sensitivity, but so far no study has looked to see if they work better when the ingredients (and modes of action) are combined. This proof of principal study will compare the toothpaste containing both ingredients with toothpastes containing a single ingredient and a regular fluoride control toothpaste.
Eligible participants will be adults with dentine hypersensitivity in at least 2 teeth who provide informed consent to take part. After enrolment at screening participants will be given a standard fluoride toothpaste to use twice daily for 2 weeks and will then return to the study site for a baseline visit. At baseline participants will be randomised to one of the four toothpastes that they will be asked to use twice-daily for the 8 weeks instead of their normal toothpaste. Participants will be asked to return to the study site a further 4 times, after 3 days and after 2, 4 and 8 weeks. At every study appointment tooth sensitivity will be assessed. Participants will be also asked to complete 2 short questionnaires about their dentine hypersensitivity at baseline and the subsequent visits. In addition, participants will be asked to complete a diary card recording their toothbrushing from enrolment until the final study appointment. Changes in clinically determined dentine hypersensitivity and in self-perceived discomfort associated with tooth sensitivity will be assessed at these timepoints.Summary of Results
Researchers wanted to see how well the products used in the study protected sensitive teeth of the participants when used twice daily for 56 days.
For this, they tested tooth sensitivity of the participants throughout the study using air and pressure as triggers. They compared the participant's results during the study to their results at the start of the study that is, at Baseline (Day 0). The researchers also compared the results of test product to other products used in the study.
Evaporative (air) trigger was applied to the test teeth using dental air syringe. Researchers scored participant's response to the trigger using a scale known as Schiff sensitivity scale. The scale had scores ranging from 0 to 3. Score 0 indicated participants did not respond to the trigger and score 3 indicated participants responded to the trigger and requested its discontinuation.
Researchers calculated mean (average) of the sensitivity score recorded for individual test teeth of the participant at Baseline (Day 0), Day 3, 14, 28 and 56. The below figure shows the results of Mean Schiff Sensitivity score over 56 Days.
A decrease in Schiff sensitivity score indicated an improvement in sensitivity protection.
Pressure was applied to the participant's teeth using a pen like device known as pressure probe. 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 continuous 'yes' responses was recorded as the tactile threshold in grams.
The below figure shows the results of Mean Tactile Threshold calculated as average of the two selected test teeth over time. An increase in tactile threshold indicated an improvement in sensitivity protection.
Researchers also calculated number of sensitive teeth at Baseline (Day 0), Day 3, 14, 28 and 56 using Schiff sensitivity scale. Sensitive teeth were defined as teeth with Schiff sensitivity score of greater than or equal to (>=)1.
The below figure shows the results of Mean Number of Sensitive Teeth over time. A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity protection.
Researchers found that participants who used test product had higher reduction in mean Schiff sensitivity score and higher increase in tactile threshold compared participants who used other study products.
They also found that the participants using test product, comparator 1, and comparator 2 had a continuous improvement in Schiff sensitivity score and tactile threshold when used over 8 weeks with twice-daily tooth brushing.REC name
Wales REC 2
REC reference
22/WA/0008
Date of REC Opinion
18 Jan 2022
REC opinion
Favourable Opinion