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Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

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ClinicalTrials.gov Identifier: NCT01657877
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : July 24, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Caries
Interventions: Drug: Calcium sodium phosphosilicate
Drug: Sodium monoflurophosphate
Drug: Placebo

  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 one clinical site (US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 95 participants were screened, of which 79 were randomized. Of the subjects who were not randomized, 11 did not meet the study criteria; 3 had protocol violations; 2 withdrew consent.

Reporting Groups
  Description
Overall Participants

In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:

  1. Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)
  2. Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP
  3. Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP
  4. Dentifrice containing 0 ppm fluoride + 0% CSP
  5. Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period.

Participant Flow:   Overall Study
    Overall Participants
STARTED   79 
Received 500ppm Fluoride as SMFP+ 0% CSP   70 [1] 
Received 1500ppm Fluoride as SMFP+5% CSP   75 [2] 
Received 0ppm Fluoride+ 5% CSP   71 [3] 
Received 0ppm Fluoride+ 0% CSP   69 [4] 
Received 1500ppm Fluoride as SMFP+0% CSP   71 [5] 
COMPLETED   65 
NOT COMPLETED   14 
Withdrawal by Subject                4 
Protocol Violation                6 
Adverse Event                2 
Other Reason                2 
[1] Discontinuations: 1 due to other reason in P2 and 1 protocol violation in P4
[2] Discontinuations:2 withdrawal of consent in period (P) 1; 1 AE in P2;1 protocol violation in P3 & P4
[3] Discontinuations: 1 protocol violation in P1 and P2 each and 1 withdrawal of consent in P1.
[4] Discontinuation: 1 in P4 due to other reasons
[5] Discontinuations: 1 protocol violation in P1 and 1 withdrawal of consent and AE in P3



  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
All Randomized Participants All randomized participants were evaluated for baseline characteristics.

Baseline Measures
   All Randomized Participants 
Overall Participants Analyzed 
[Units: Participants]
 79 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.5  (9.60) 
Gender 
[Units: Participants]
 
Female   46 
Male   33 


  Outcome Measures

1.  Primary:   Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.   [ Time Frame: Baseline to 21 days ]

2.  Secondary:   Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.   [ Time Frame: Baseline to 21 days ]

3.  Secondary:   Enamel Fluoride Uptake (EFU)   [ Time Frame: Baseline to 21 days ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657877     History of Changes
Other Study ID Numbers: RH01381
First Submitted: August 2, 2012
First Posted: August 6, 2012
Results First Submitted: June 19, 2014
Results First Posted: July 24, 2014
Last Update Posted: October 1, 2014