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Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563172
First Posted: March 26, 2012
Last Update Posted: September 13, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: April 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Dental Caries
Interventions: Drug: Sodium fluoride / silica and carbopol, 0.5g
Drug: Sodium fluoride / silica and carbopol, 1.5g
Other: Fluoride free dentifrice

  Participant Flow
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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 from 1 center in the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures.

Reporting Groups
  Description
Overall This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.

Participant Flow:   Overall Study
    Overall
STARTED   65 
Experimental Dentifrice 0.5g/2 Min   59 
Experimental Dentifrice 0.5g/45 Sec   59 
Experimental Dentifrice 1.5g/ 2min   58 
Experimental Dentifrice 1.5g/ 45 Sec   58 
Control Dentifrice   60 
COMPLETED   52 
NOT COMPLETED   13 
Adverse Event                5 
Lost to Follow-up                2 
Other (Protocol deviation)                5 
Other (Not specified)                1 



  Baseline Characteristics
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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.
Safety population: The overall Safety Population included all the participants who were randomized and used at least one of the treatment dentifrices during the study and had at least one safety assessment (e.g. assessment of adverse events [AEs] or had an oral soft tissue examination) after using the treatment dentifrices.

Reporting Groups
  Description
Overall This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.

Baseline Measures
   Overall 
Overall Participants Analyzed 
[Units: Participants]
 65 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.6  (8.56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      38  58.5% 
Male      27  41.5% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   28 
Black   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.   [ Time Frame: At Baseline and at Day 14 ]

2.  Secondary:   Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.   [ Time Frame: At Baseline and at Day 14 ]

3.  Secondary:   Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.   [ Time Frame: At Baseline and at Day 14 ]

4.  Secondary:   Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.   [ Time Frame: At Baseline and at Day 14 ]

5.  Secondary:   Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.   [ Time Frame: At Baseline and at Day 14 ]

6.  Secondary:   Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.   [ Time Frame: At Day 14 ]

7.  Secondary:   Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.   [ Time Frame: At Day 14 ]

8.  Secondary:   Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.   [ Time Frame: At Day 14 ]

9.  Secondary:   Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.   [ Time Frame: At Day 14 ]

10.  Secondary:   Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.   [ Time Frame: At Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT01563172     History of Changes
Other Study ID Numbers: T3158587
First Submitted: February 16, 2012
First Posted: March 26, 2012
Results First Submitted: April 27, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 13, 2017