N/A
N=30
A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02406573 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline for Visual Analog Scale - Cold Water — -22.93 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Crest® Sensi-Stop™ Strips (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Visual Analog Scale - Cold Water |
-22.93 | — |
| PRIMARY Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index |
-0.17 | — |
| PRIMARY Change From Baseline for 5 Face Emoticon Scale |
-1.07 | — |
Summary
This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.
Eligibility Criteria
Inclusion Criteria
- be at least 18 years of age
- sign an informed consent form and be given a copy
- be in good general health as determined by the Investigator/designee
- agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
- agree to not participate in any other oral care study for the duration of this study
- agree to return for scheduled visits and follow all study procedures
- have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the examiner applied cold water challenge
Exclusion Criteria
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- active treatment for periodontitis
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- fixed facial orthodontic appliances
- a history of kidney stones
- self-reported pregnancy or nursing
- known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
Data sourced from ClinicalTrials.gov (NCT02406573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.