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Trial record 69 of 292 for:    Sodium Fluoride OR Duraphat

A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02384044
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : May 21, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Device: Crest® Sensi-Stop™ Strips
Device: Colgate® Sensitivity Relief Pen
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Hide Arm/Group Description

Professionally Applied

Crest® Sensi-Stop™ Strips

Professionally Applied

Colgate® Sensitivity Relief Pen

Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen Total
Hide Arm/Group Description

Professionally Applied

Crest® Sensi-Stop™ Strips

Professionally Applied

Colgate® Sensitivity Relief Pen

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
43.2  (7.97) 43.5  (7.77) 43.4  (7.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
6
  40.0%
10
  66.7%
16
  53.3%
Male
9
  60.0%
5
  33.3%
14
  46.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Asian Oriental
0
   0.0%
1
   6.7%
1
   3.3%
Black
1
   6.7%
1
   6.7%
2
   6.7%
Caucasian
14
  93.3%
13
  86.7%
27
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Change From Baseline Visual Analog Scale
Hide Description Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty (30) subjects received study products and completed the study.
Arm/Group Title Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Hide Arm/Group Description:

Professionally Applied

Crest® Sensi-Stop™ Strips

Professionally Applied

Colgate® Sensitivity Relief Pen

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-22.933  (19.252) -3.200  (11.857)
2.Secondary Outcome
Title Change From Baseline for Air Challenge
Hide Description The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty (30) subjects received study product and completed the study.
Arm/Group Title Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Hide Arm/Group Description:

Professionally Applied

Crest® Sensi-Stop™ Strips

Professionally Applied

Colgate® Sensitivity Relief Pen

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.800  (0.561) 0.000  (0.378)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Hide Arm/Group Description

Professionally Applied

Crest® Sensi-Stop™ Strips

Professionally Applied

Colgate® Sensitivity Relief Pen

All-Cause Mortality
Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Crest® Sensi-Stop™ Strips Colgate® Sensitivity Relief Pen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      1/15 (6.67%)    
Gastrointestinal disorders     
Cheilitis * 1 [1]  0/15 (0.00%)  0 1/15 (6.67%)  1
Stomatitis * 1  2/15 (13.33%)  2 0/15 (0.00%)  0
1
Term from vocabulary, COSTART
*
Indicates events were collected by non-systematic assessment
[1]
Cheilitis
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: The Procter & Gamble Company
Phone: 513-622-2489
EMail: peters.j.2@pg.com
Layout table for additonal information
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02384044     History of Changes
Other Study ID Numbers: 2015012
First Submitted: March 4, 2015
First Posted: March 10, 2015
Results First Submitted: April 26, 2019
Results First Posted: May 21, 2019
Last Update Posted: June 25, 2019