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Trial record 3 of 108 for:    CALCIUM CATION

Intra Oral Kinetics of Fluoride Containing Dentifrices

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ClinicalTrials.gov Identifier: NCT02548156
Recruitment Status : Completed
First Posted : September 14, 2015
Results First Posted : July 27, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Tooth Erosion
Interventions Other: Test Dentifrice
Other: Reference Dentifrice
Other: Comparator Dentifrice
Other: Orange Juice
Other: De-ionised water
Enrollment 29
Recruitment Details Participants were recruited at one Centre United Kingdom.
Pre-assignment Details A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.
Arm/Group Title Sequence 1: Test/Comparator/Reference: Dentifrice Sequence 2: Test/Reference/Comparator: Dentifrice Sequence 3: Comparator/Test/Reference: Dentifrice Sequence 4: Comparator/Reference/Test: Dentifrice Sequence 5: Reference/Test/Comparator: Dentifrice Sequence 6: Reference/Comparator/Test: Dentifrice
Hide Arm/Group Description Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
Period Title: Period 1
Started 5 5 4 5 5 5
Completed 5 5 4 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 1
Started 5 5 4 5 5 5
Completed 5 5 4 5 4 5
Not Completed 0 0 0 0 1 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             1             0
Period Title: Period 2
Started 5 5 4 5 4 5
Completed 5 5 4 5 4 5
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 2
Started 5 5 4 5 4 5
Completed 5 5 4 5 4 5
Not Completed 0 0 0 0 0 0
Period Title: Period 3
Started 5 5 4 5 4 5
Completed 5 5 4 5 4 5
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description All the participants randomized in this study.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
34.8  (9.12)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
23
  79.3%
Male
6
  20.7%
1.Primary Outcome
Title Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
Hide Description Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Arm/Group Title Test Dentifrice Reference Dentifrice Comparator Dentifrice
Hide Arm/Group Description:
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Overall Number of Participants Analyzed 28 28 28
Least Squares Mean (Standard Error)
Unit of Measure: parts per million(ppm)
0.23  (0.0469) 0.23  (0.0430) 0.15  (0.0485)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Dentifrice, Reference Dentifrice, Comparator Dentifrice
Comments Test and Reference dentifrice combined vs. Comparator dentifrice
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS mean
Estimated Value 1.52
Estimation Comments Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio >1 favors the first named treatment.
2.Secondary Outcome
Title Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Hide Description Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
Time Frame up to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Arm/Group Title Test Dentifrice Reference Dentifrice Comparator Dentifrice
Hide Arm/Group Description:
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Overall Number of Participants Analyzed 28 28 28
Mean (Standard Error)
Unit of Measure: ppm
Fluoride: At baseline (n=26, 28, 26) 0.045  (0.0125) 0.032  (0.0084) 0.031  (0.0072)
Fluoride: At 1 minute (n=27, 28, 26) 8.775  (0.8301) 8.794  (1.0562) 7.630  (0.7497)
Fluoride: At 5 minute (n=27, 27, 27) 3.881  (0.4115) 4.132  (0.4759) 3.492  (0.4664)
Fluoride: At 10 minute (n=26, 26, 26) 1.831  (0.1980) 1.951  (0.2654) 1.476  (0.1524)
Fluoride: At 15 minute (n=27, 27, 26) 1.346  (0.1827) 1.188  (0.1550) 0.942  (0.1432)
Fluoride: At 30 minute (n=26, 27, 27) 0.656  (0.1065) 0.600  (0.0810) 0.479  (0.0723)
Calcium: At Baseline (n=26, 25, 22) 29.749  (0.9428) 28.357  (1.0162) 28.661  (1.0657)
Calcium: At 1 minute (n=23, 28, 25) 28.300  (1.5171) 27.217  (1.0689) 14.931  (1.0999)
Calcium: At 5 minute (n=16, 17, 22) 27.818  (1.3743) 26.070  (1.4638) 17.227  (0.9170)
Calcium: At 10 minute (n=16, 16, 21) 27.472  (1.0061) 25.672  (1.1944) 20.133  (1.0395)
Calcium: At 15 minute (n=18, 20, 20) 28.319  (1.0783) 27.227  (0.8656) 23.761  (1.2803)
Calcium: At 30 minute (n=17, 18, 20) 28.650  (1.0725) 27.323  (1.0325) 24.196  (1.3196)
Calcium: At 60 minute (n=23, 20, 22) 28.198  (1.0073) 27.094  (1.0560) 27.104  (1.3777)
3.Secondary Outcome
Title Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Hide Description Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Arm/Group Title Test Dentifrice Reference Dentifrice Comparator Dentifrice
Hide Arm/Group Description:
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Overall Number of Participants Analyzed 28 28 28
Least Squares Mean (Standard Error)
Unit of Measure: ppm
Fluoride Ion concentration(n=27, 28, 27) 0.349  (0.0349) 0.169  (0.1104) 0.277  (0.1601)
Calcium Ion concentration (n=26, 22, 25) 15.015  (4.3355) 27.263  (4.7113) 14.805  (4.0473)
4.Secondary Outcome
Title Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Hide Description Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Time Frame up to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Arm/Group Title Test Dentifrice Reference Dentifrice Comparator Dentifrice
Hide Arm/Group Description:
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Overall Number of Participants Analyzed 28 28 28
Mean (Standard Deviation)
Unit of Measure: ppm
Fluoride: In initial expectorate 178.522  (61.1593) 168.728  (54.3780) 164.708  (54.2632)
Fluoride: Post-Brushing De-Ionised Water Rinse Ex 8.377  (4.2346) 7.721  (4.1721) 7.443  (3.4546)
Fluoride: 60 Minutes Post Brushing 0.166  (0.0609) 0.046  (0.0370) 0.135  (0.0563)
Calcium: In initial expectorate 17.096  (4.7864) 17.467  (4.1241) 2.500  (0.0000)
Calcium: Post-Brushing De-Ionised Water Rinse Ex 4.959  (2.2712) 4.438  (2.2141) 2.500  (0.0000)
Calcium: 60 Minutes Post Brushing 96.165  (9.2357) 4.600  (2.0507) 99.189  (17.2771)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Dentifrice Reference Dentifrice Comparator Dentifrice
Hide Arm/Group Description 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
All-Cause Mortality
Test Dentifrice Reference Dentifrice Comparator Dentifrice
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Dentifrice Reference Dentifrice Comparator Dentifrice
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%)   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 1%
Test Dentifrice Reference Dentifrice Comparator Dentifrice
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/28 (28.57%)   3/29 (10.34%)   5/28 (17.86%) 
Gastrointestinal disorders       
Chapped Lips  1/28 (3.57%)  0/29 (0.00%)  0/28 (0.00%) 
Nausea  1/28 (3.57%)  0/29 (0.00%)  0/28 (0.00%) 
General disorders       
Device failure  1/28 (3.57%)  0/29 (0.00%)  0/28 (0.00%) 
Medical device complication  1/28 (3.57%)  0/29 (0.00%)  0/28 (0.00%) 
Malaise  0/28 (0.00%)  1/29 (3.45%)  0/28 (0.00%) 
Vaccination site pain  0/28 (0.00%)  1/29 (3.45%)  0/28 (0.00%) 
Infections and infestations       
Influenza  0/28 (0.00%)  0/29 (0.00%)  1/28 (3.57%) 
Oral herpes  0/28 (0.00%)  0/29 (0.00%)  2/28 (7.14%) 
Rhinitis  0/28 (0.00%)  0/29 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications       
Mouth injury  2/28 (7.14%)  0/29 (0.00%)  1/28 (3.57%) 
Thermal burn  0/28 (0.00%)  1/29 (3.45%)  0/28 (0.00%) 
Nervous system disorders       
Headache  1/28 (3.57%)  0/29 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain  1/28 (3.57%)  0/29 (0.00%)  0/28 (0.00%) 
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02548156     History of Changes
Other Study ID Numbers: 204777
First Submitted: September 10, 2015
First Posted: September 14, 2015
Results First Submitted: June 16, 2016
Results First Posted: July 27, 2016
Last Update Posted: January 18, 2017