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Trial record 98 of 292 for:    Sodium Fluoride OR Duraphat

An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy

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: NCT01665911
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : August 21, 2014
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
The Borrow Foundation
Information provided by (Responsible Party):
Frank Lippert, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor)
Condition Caries
Interventions Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Drug: 3 mg sodium fluoride in 100 ml milk
Drug: 3 mg sodium fluoride in 200 ml milk
Other: Non-fluoridated milk, 200 ml
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description

Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:

  1. . 1.5 mg Sodium Fluoride in 100 ml milk: .
  2. 1.5 mg Sodium Fluoride in 200 ml milk
  3. 3.0 mg Sodium Fluoride in 100 ml milk
  4. 3.0 mg Sodium Fluoride in 200 ml milk
  5. 0 mg fluoride in 200 ml milk
Period Title: Overall Study
Started 28
0 mg Fluoride in 200 ml Milk 22
1.5 mg Sodium Fluoride in 100 ml Milk 23
1.5 mg Sodium Fluoride in 200 ml Milk 25
3.0 mg Sodium Fluoride in 100 ml Milk 22
3.0 mg Sodium Fluoride in 200 ml Milk 22
Completed 22
Not Completed 6
Reason Not Completed
Protocol Violation             4
Withdrawal by Subject             1
Adverse Event             1
Arm/Group Title All Participants
Hide Arm/Group Description
  1. 1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
  2. 1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
  3. 3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.
  4. 3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design
  5. Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
63  (10)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  53.6%
>=65 years
13
  46.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
17
  60.7%
Male
11
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title % Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
Hide Description
  • surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:
  • SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).
Time Frame Three Weeks per each of five arms
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml

Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: percent
0 mg fluoride in 200 ml milk 20  (2)
1.5 mg fluoride in 100 ml milk 24  (2)
1.5 mg fluoride in 200 ml milk 22.5  (1.9)
3.0 mg fluoride in 100 ml milk 26.7  (2)
3.0 mg fluoride in 200 ml milk 25.4  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0490
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0423
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments 3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title % Acid Resistance Score Per Each of Five Arms
Hide Description % Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
Time Frame Three Weeks per each of five arms
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:

  1. . 1.5 mg Sodium Fluoride in 100 ml milk: .
  2. 1.5 mg Sodium Fluoride in 200 ml milk
  3. 3.0 mg Sodium Fluoride in 100 ml milk
  4. 3.0 mg Sodium Fluoride in 200 ml milk
  5. 0 mg fluoride in 200 ml milk
Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: percent
0 mg fluoride in 200 ml milk -3.4  (2.0)
1.5 mg fluoride in 100 ml milk 2.6  (2.0)
1.5 mg fluoride in 200 ml milk -0.2  (1.9)
3.0 mg fluoride in 100 ml milk 5.4  (2.0)
3.0 mg fluoride in 200 ml milk 6.0  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0269
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments 3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Enamel Fluoride Uptake Per Each of Five Arms
Hide Description Enamel fluoride uptake is a measure of fluoridation of a caries lesion
Time Frame Three Weeks per each of five arms
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:

1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml

Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use.

Overall Number of Participants Analyzed 22
Least Squares Mean (Standard Error)
Unit of Measure: microgram fluoride per square cm
0 mg fluoride in 200 ml milk 1.2  (0.18)
1.5 mg fluoride in 100 ml milk 2.4  (0.17)
1.5 mg fluoride in 200 ml milk 2.12  (0.17)
3.0 mg fluoride in 100 ml milk 3.09  (0.18)
3.0 mg fluoride in 200 ml milk 2.67  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments 1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments 1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0444
Comments 3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk
Method ANOVA
Comments [Not Specified]
Time Frame Six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm/Group All Participants
Hide Arm/Group Description

1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml

1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.

1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.

3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.

3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design

Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design.

All-Cause Mortality
Arm/Group All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm/Group All Participants
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm/Group All Participants
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frank Lippert
Organization: Indiana University School of Dentistry
Phone: 317-274-8822
EMail: flippert@iu.edu
Layout table for additonal information
Responsible Party: Frank Lippert, Indiana University
ClinicalTrials.gov Identifier: NCT01665911     History of Changes
Other Study ID Numbers: 12-I-086
First Submitted: August 7, 2012
First Posted: August 16, 2012
Results First Submitted: August 5, 2014
Results First Posted: August 21, 2014
Last Update Posted: February 23, 2015