Trial Outcomes & Findings for An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy (NCT NCT01665911)

NCT ID: NCT01665911

Last Updated: 2015-02-23

Results Overview

* 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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Three Weeks per each of five arms
• Results posted on: 2015-02-23

Participant Flow

Participant milestones

Measure	All Participants 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 Study STARTED	28
Overall Study 0 mg Fluoride in 200 ml Milk	22
Overall Study 1.5 mg Sodium Fluoride in 100 ml Milk	23
Overall Study 1.5 mg Sodium Fluoride in 200 ml Milk	25
Overall Study 3.0 mg Sodium Fluoride in 100 ml Milk	22
Overall Study 3.0 mg Sodium Fluoride in 200 ml Milk	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	All Participants 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 Study Protocol Violation	4
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Participants n=28 Participants 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
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Three Weeks per each of five arms

• 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).

Outcome measures

Measure	All Participants n=22 Participants 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
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms 0 mg fluoride in 200 ml milk	20 percent Standard Error 2
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms 1.5 mg fluoride in 100 ml milk	24 percent Standard Error 2
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms 1.5 mg fluoride in 200 ml milk	22.5 percent Standard Error 1.9
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms 3.0 mg fluoride in 100 ml milk	26.7 percent Standard Error 2
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms 3.0 mg fluoride in 200 ml milk	25.4 percent Standard Error 2

SECONDARY outcome

Timeframe: Three Weeks per each of five arms

% 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.

Outcome measures

Measure	All Participants n=22 Participants 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
% Acid Resistance Score Per Each of Five Arms 1.5 mg fluoride in 100 ml milk	2.6 percent Standard Error 2.0
% Acid Resistance Score Per Each of Five Arms 1.5 mg fluoride in 200 ml milk	-0.2 percent Standard Error 1.9
% Acid Resistance Score Per Each of Five Arms 3.0 mg fluoride in 100 ml milk	5.4 percent Standard Error 2.0
% Acid Resistance Score Per Each of Five Arms 0 mg fluoride in 200 ml milk	-3.4 percent Standard Error 2.0
% Acid Resistance Score Per Each of Five Arms 3.0 mg fluoride in 200 ml milk	6.0 percent Standard Error 2.0

SECONDARY outcome

Timeframe: Three Weeks per each of five arms

Enamel fluoride uptake is a measure of fluoridation of a caries lesion

Outcome measures

Measure	All Participants n=22 Participants 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
Enamel Fluoride Uptake Per Each of Five Arms 3.0 mg fluoride in 100 ml milk	3.09 microgram fluoride per square cm Standard Error 0.18
Enamel Fluoride Uptake Per Each of Five Arms 3.0 mg fluoride in 200 ml milk	2.67 microgram fluoride per square cm Standard Error 0.18
Enamel Fluoride Uptake Per Each of Five Arms 0 mg fluoride in 200 ml milk	1.2 microgram fluoride per square cm Standard Error 0.18
Enamel Fluoride Uptake Per Each of Five Arms 1.5 mg fluoride in 100 ml milk	2.4 microgram fluoride per square cm Standard Error 0.17
Enamel Fluoride Uptake Per Each of Five Arms 1.5 mg fluoride in 200 ml milk	2.12 microgram fluoride per square cm Standard Error 0.17

Adverse Events

Arm/Group All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frank Lippert

Indiana University School of Dentistry

Phone: 317-274-8822

Email: flippert@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place