A01
OtherSubjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period
NCT Number: NCT02789618
Subjects with at least two teeth with dentinal hypersensitivity and who meet the study criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash out period). Baseline dentine hypersensitivity assessments will be conducted using tactile stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP) questionnaire will be completed at four defined time points during the study. The baseline assessments will be conducted on the two teeth identified during the screening visit.
On completion of the baseline assessments, subjects will be randomly assigned to product. Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product use.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals with the following conditions will not be eligible for participation in the study:
Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period
Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The bonding agent will be professional applied immediately prior to the clinical assessments.
Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.
Time frame: Baseline, 18 days, 29 days and 57 days
Reduction in pain caused by dentin hypersensitivity will be measured using the Jay Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
Time frame: Baseline, 18 days, 29 days and 57 days
Reduction in pain caused by dentin hypersensitivity will be measured using the Yeaple Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
Time frame: Baseline, 18 days, 29 days and 57 days
Reduction in pain caused by dentin hypersensitivity will be measured using the Schiff assessment (Air Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
Time frame: Baseline, 18 days, 29 days and 57 days
Specific quality of life attributes and the impact of dentin hypersensitivity on subject's daily life will be measured (subjective measure)
Time frame: Baseline, 18 days, 29 days and 57 days
Reduction in pain caused by dentin hypersensitivity will be measured using the Visual Analogue Scale (VAS) on day 18, day 29 and day 57 and compared to the baseline measurement
Unilever R&D
Industry
A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe by Correlating the Results With the Those of Yeaple Probe, Schiff Air Blast, Visual Analogue Scale (VAS) and Oral Health Impact Profile Questionnaire (OHIP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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