Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT02476032
The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter & Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips (Procter & Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter & Gamble™) effectiveness when the product is placed by a dental professional compared to self-placement by the person with sensitive teeth. This product is not experimental.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55455, United States
There are two groups in this research study: 1) The Self Applied group, and 2) the Professionally Applied group.
Once it is determined that interested individuals qualify to participate in the study and have determined that they want to participate, the group that participants are in will be determined. The study has been designed to ensure that 66% of the study participants receives strips that contain the active ingredient and 33% of the subjects receive strips without the active ingredient. This means that there is a 1 out of 3 chance that participants will be assigned to receive the strip(s) without the active desensitizing ingredient. At the end of your 8-week participation, if it turns out that participants received the strips without the active ingredient, they will be offered a sample pack with two strips that contain the active desensitizing ingredient for them to use at home.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. Schiff Air Scale = equal to or greater than 1
ii. Verbal Rating Scale = equal to or greater than 1
iii. Recession= 1mm or greater
Exclusion criteria
Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
Time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.
Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity
0 Tooth/Patient did not respond to the air stimulus
Time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.
Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain
0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain
University of Minnesota
Other
Acronym: SSDH
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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