Enamel Remineralization Potential of Dentifrices in Situ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128946
First received: May 20, 2010
Last updated: January 23, 2014
Last verified: August 2013
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Dental Caries
Interventions: Drug: NaF
Drug: SnF
Drug: NaMFP

  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 at the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two to three days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed with the study wash out toothpaste and toothbrush.

Reporting Groups
  Description
Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
NaF Toothpaste (675ppmF Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.

Participant Flow for 4 periods

Period 1:   Period I
    Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F     Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF     Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF     NaF Toothpaste (675ppmF  
STARTED     20     21     21     21  
COMPLETED     20     20     20     20  
NOT COMPLETED     0     1     1     1  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 0                 0                 1                 1  

Period 2:   Period II
    Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F     Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF     Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF     NaF Toothpaste (675ppmF  
STARTED     20 [1]   20 [1]   20 [1]   20 [1]
COMPLETED     20     19     20     19  
NOT COMPLETED     0     1     0     1  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 0                 0                 0                 1  
[1] Due to crossover design, different set of participants received this treatment compared to Period I

Period 3:   Period III
    Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F     Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF     Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF     NaF Toothpaste (675ppmF  
STARTED     20 [1]   19 [1]   20 [1]   19 [1]
COMPLETED     19     19     20     19  
NOT COMPLETED     1     0     0     0  
Protocol Violation                 1                 0                 0                 0  
[1] Due to crossover design, different set of participants received this treatment compared to Period II

Period 4:   Period IV
    Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F     Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF     Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF     NaF Toothpaste (675ppmF  
STARTED     19 [1]   20 [1]   19 [1]   19 [1]
COMPLETED     19     20     19     19  
NOT COMPLETED     0     0     0     0  
[1] Due to crossover design,different set of participants received this treatment compared to Period III



  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.
No text entered.

Reporting Groups
  Description
Overall All randomized participants

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  83  
Age  
[units: Years]
Mean ± Standard Deviation
  64.0  ± 8.73  
Gender  
[units: Participants]
 
Female     48  
Male     35  
Region of Enrollment  
[units: Participants]
 
United States     83  



  Outcome Measures
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1.  Primary:   Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)   [ Time Frame: Baseline to 14 days ]

2.  Secondary:   %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)   [ Time Frame: Baseline to 14 days ]

3.  Secondary:   Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)   [ Time Frame: Baseline to 14 days ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01128946     History of Changes
Other Study ID Numbers: T3500690
Study First Received: May 20, 2010
Results First Received: March 21, 2013
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration