Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01115452
First received: April 30, 2010
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Dentine Hypersensitivity
Interventions: Drug: 5% Potassium nitrate
Drug: 2.5% Potassium nitrate
Other: Sterile water

  Participant Flow
  Hide 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 the clinical site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with at least three non-adjacent sensitive teeth were included in the study. Each participant received three treatments during each of the five days treatment. Treatments were randomly assigned to each of the three individual sensitive tooth.

Reporting Groups
  Description
5% or 2.5% Potassium Nitrate Solution or Water Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.

Participant Flow:   Overall Study
    5% or 2.5% Potassium Nitrate Solution or Water  
STARTED     32  
COMPLETED     32  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
Overall Study No text entered.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  32  
Age  
[units: Years]
Mean (Standard Deviation)
  36.5  (11.63)  
Gender  
[units: Participants]
 
Female     27  
Male     5  
Region of Enrollment  
[units: Participants]
 
United States     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution   [ Time Frame: Baseline and immediately after treatment on Day 5 ]

2.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS   [ Time Frame: Baseline and immediately after treatment on Day 1 ]

3.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS   [ Time Frame: Baseline and 10 mins post treatment on Day 1 ]

4.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.   [ Time Frame: Baseline and 20 mins post treatment on Day 1 ]

5.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS   [ Time Frame: Baseline and immediately after treatment on Day 2 ]

6.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS   [ Time Frame: Baseline and 10 mins post treatment on Day 2 ]

7.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS   [ Time Frame: Baseline and 20 mins post treatment on Day 2 ]

8.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS   [ Time Frame: Baseline and immediately after treatment on Day 3 ]

9.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS   [ Time Frame: Baseline and 10 mins post treatment on Day 3 ]

10.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS   [ Time Frame: Baseline and 20 mins post treatment on Day 3 ]

11.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS   [ Time Frame: Baseline and immediately after treatment on Day 4 ]

12.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS   [ Time Frame: Baseline and 10 mins post treatment on Day 4 ]

13.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS   [ Time Frame: Baseline and 20 mins post treatment on Day 4 ]

14.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water   [ Time Frame: Baseline and immediately after treatment on Day 5 ]

15.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS   [ Time Frame: Baseline and 10 mins post treatment on Day 5 ]

16.  Secondary:   Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS   [ Time Frame: Baseline and 20 mins post treatment on Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01115452     History of Changes
Other Study ID Numbers: Z3770633
Study First Received: April 30, 2010
Results First Received: March 21, 2013
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration