We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

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: NCT03072719
Recruitment Status : Completed
First Posted : March 7, 2017
Results First Posted : April 18, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dentine Hypersensitivity
Interventions: Drug: Stannous Fluoride
Drug: Sodium Monofluorophosphate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at a single center in Ireland.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 394 participants were screened, out of which 120 participants were randomized. 274 participants were not randomized because 248 participants did not meet the study criteria, 4 participants were lost to follow up, and 7 participants withdrew the consent and 15 participants for other reasons (not-specified).

Reporting Groups
  Description
Experimental Dentifrice Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
Reference Dentifrice Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.

Participant Flow:   Overall Study
    Experimental Dentifrice   Reference Dentifrice
STARTED   60   60 
COMPLETED   59   59 
NOT COMPLETED   1   1 
Adverse Event                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental Dentifrice Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
Reference Dentifrice Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
Total Total of all reporting groups

Baseline Measures
   Experimental Dentifrice   Reference Dentifrice   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   60   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.4  (12.85)   30.7  (11.66)   29.5  (12.27) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  58.3%      40  66.7%      75  62.5% 
Male      25  41.7%      20  33.3%      45  37.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   1.7%      1   1.7%      2   1.7% 
Not Hispanic or Latino      59  98.3%      59  98.3%      118  98.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   1.7%      1   0.8% 
White      60 100.0%      59  98.3%      119  99.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change From Baseline in Schiff Sensitivity Score on Day 14   [ Time Frame: Baseline, Day 14 ]

2.  Secondary:   Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3   [ Time Frame: Baseline, post first brushing (after 5 minutes) and Day 3 ]

3.  Secondary:   Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14   [ Time Frame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03072719     History of Changes
Obsolete Identifiers: NCT01724008
Other Study ID Numbers: 202161
First Submitted: March 2, 2017
First Posted: March 7, 2017
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: July 12, 2017