Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01563172
Collaborator
(none)
65
1
5
5
13.1
Study Details
Study Description
Brief Summary
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
Actual Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental dentifrice 0.5g, 45 seconds brushing group Participants brush twice a daily for 45 seconds with experimental dentifrice. |
Drug: Sodium fluoride / silica and carbopol, 0.5g
Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
Other: Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period
|
| Experimental: Experimental dentifrice 1.5g, 45 seconds brushing group Participants brush twice a daily for 45 seconds with experimental dentifrice. |
Drug: Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Other: Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period
|
| Experimental: Experimental dentifrice 0.5g, 2 minutes brushing group Participants brush twice a daily for 2 minutes with experimental dentifrice. |
Drug: Sodium fluoride / silica and carbopol, 0.5g
Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
Other: Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period
|
| Experimental: Experimental dentifrice 1.5g, 2 minutes brushing group Participants brush twice a daily for 2 minutes with experimental dentifrice. |
Drug: Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Other: Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period
|
| Active Comparator: Contol group Participants brush twice a daily for 2 minutes with controll dentifrice. |
Drug: Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Other: Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period
|
Outcome Measures
Primary Outcome Measures
- Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [At Baseline and at Day 14]
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Secondary Outcome Measures
- Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. [At Baseline and at Day 14]
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
- Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. [At Baseline and at Day 14]
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
- Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [At Baseline and at Day 14]
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
- Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice. [At Baseline and at Day 14]
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
- Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [At Day 14]
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
- Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. [At Day 14]
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
- Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. [At Day 14]
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
- Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [At Day 14]
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
- Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice. [At Day 14]
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
General and Dental Health
-
Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
-
Have no current active caries or periodontal disease that may compromise the study or the health of the subjects
-
Residency: Currently living in the Indianapolis, Indiana area
Dentures:
-
Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 mm x 7 mm)
-
Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
-
All restorations in a good state of repair
-
Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute)
Exclusion Criteria:
-
Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
-
Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
-
A member of the site study staff who is directly working on the project or living in that staff's household
-
Any employee of any toothpaste manufacturer or their spouse or family member
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University School of Dentistry | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563172
Other Study ID Numbers:
- T3158587
First Posted:
Mar 26, 2012
Last Update Posted:
Feb 7, 2018
Last Verified:
Jan 1, 2018
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 1 center in the USA. |
|---|---|
| Pre-assignment Detail | Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures. |
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only. |
| Period Title: Overall Study | |
| STARTED | 65 |
| Experimental Dentifrice 0.5g/2 Min | 59 |
| Experimental Dentifrice 0.5g/45 Sec | 59 |
| Experimental Dentifrice 1.5g/ 2min | 58 |
| Experimental Dentifrice 1.5g/ 45 Sec | 58 |
| Control Dentifrice | 60 |
| COMPLETED | 52 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only. |
| Overall Participants | 65 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
63.6
(8.56)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
38
58.5%
|
| Male |
27
41.5%
|
| Race/Ethnicity, Customized (Number) [Number] | |
| Caucasian |
28
43.1%
|
| Black |
37
56.9%
|
Outcome Measures
| Title | Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. |
| Time Frame | At Baseline and at Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. |
| Measure Participants | 57 | 53 |
| Least Squares Mean (Standard Error) [% SMH] |
41.61
(2.244)
|
34.66
(2.284)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0008 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square (LS) mean difference |
| Estimated Value | 6.95 | |
| Confidence Interval |
(2-Sided) 95% 2.91 to 10.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. |
|---|---|
| Description | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. |
| Time Frame | At Baseline and at Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. |
| Measure Participants | 58 | 55 |
| Least Squares Mean (Standard Error) [% SMH] |
30.75
(2.232)
|
25.05
(2.266)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0049 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 5.70 | |
| Confidence Interval |
(2-Sided) 95% 1.74 to 9.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. |
| Time Frame | At Baseline and at Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. |
| Measure Participants | 58 | 57 |
| Least Squares Mean (Standard Error) [% SMH] |
30.75
(2.232)
|
41.61
(2.244)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -10.86 | |
| Confidence Interval |
(2-Sided) 95% -14.77 to -6.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. |
| Time Frame | At Baseline and at Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. |
| Measure Participants | 55 | 53 |
| Least Squares Mean (Standard Error) [% SMH] |
25.05
(2.266)
|
34.66
(2.284)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -9.61 | |
| Confidence Interval |
(2-Sided) 95% -13.68 to -5.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice. |
|---|---|
| Description | SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. |
| Time Frame | At Baseline and at Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice. |
| Measure Participants | 57 | 58 |
| Least Squares Mean (Standard Error) [% SMH] |
41.61
(2.244)
|
26.23
(2.232)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 15.38 | |
| Confidence Interval |
(2-Sided) 95% 11.45 to 19.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. |
| Time Frame | At Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. |
| Measure Participants | 57 | 53 |
| Least Squares Mean (Standard Error) [micrograms (μg)×F/centimeters(cm)2] |
2426.51
(103.802)
|
1912.51
(106.620)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 514.01 | |
| Confidence Interval |
(2-Sided) 95% 283.02 to 744.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. |
|---|---|
| Description | EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. |
| Time Frame | At Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. |
| Measure Participants | 58 | 55 |
| Least Squares Mean (Standard Error) [μg×F/cm2] |
1603.63
(103.018)
|
1337.72
(105.260)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0218 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | 265.92 | |
| Confidence Interval |
(2-Sided) 95% 39.00 to 492.83 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. |
| Time Frame | At Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. |
| Measure Participants | 58 | 57 |
| Least Squares Mean (Standard Error) [μg×F/cm2] |
1603.63
(103.018)
|
2426.51
(103.802)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -822.88 | |
| Confidence Interval |
(2-Sided) 95% -1047.34 to -598.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. |
|---|---|
| Description | EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. |
| Time Frame | At Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. |
| Measure Participants | 55 | 53 |
| Least Squares Mean (Standard Error) [μg×F/cm2] |
1337.72
(105.260)
|
1912.51
(106.620)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -574.79 | |
| Confidence Interval |
(2-Sided) 95% -808.08 to -341.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
| Title | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice. |
|---|---|
| Description | EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. |
| Time Frame | At Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments. |
| Arm/Group Title | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group |
|---|---|---|
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice. |
| Measure Participants | 57 | 58 |
| Least Squares Mean (Standard Error) [μg×F/cm2] |
2426.51
(103.802)
|
1132.18
(103.044)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect). | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 1294.34 | |
| Confidence Interval |
(2-Sided) 95% 1069.24 to 1519.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean from ANOVA with factors for treatment, study period, and participant (random effect). Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment. | |
Adverse Events
| Time Frame | Approximately 16 Weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder. | |||||||||
| Arm/Group Title | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group | |||||
| Arm/Group Description | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice. | |||||
All Cause Mortality |
||||||||||
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
Serious Adverse Events |
||||||||||
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/59 (18.6%) | 8/59 (13.6%) | 12/58 (20.7%) | 10/58 (17.2%) | 10/60 (16.7%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gingival mucosa imprint from teeth 28 and 29 | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Erythema anterior hard palate | 1/59 (1.7%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gingival mucosa edentulous maxillary anterior ridge erythema | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Swelling of right inside of mouth & lip caused by biting | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Ulceration on gingival lingual 26 ~2mm (millimeter) | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gingival mucosa cervical lingual area swollen with exudate | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gingival mucosa erythema of right posterior edentulous ridge | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gingival mucosa erythema left posterior edentulous ridge | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| White coating on tongue | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Sore area on ridge area #22 from partial | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Submandibular area small ulcer not painful | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gingival mucosa erythema lingual tooth 23 | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Labial mucosa chapped lips upper & lower | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| General disorders | ||||||||||
| Common cold | 3/59 (5.1%) | 2/59 (3.4%) | 3/58 (5.2%) | 2/58 (3.4%) | 1/60 (1.7%) | |||||
| Cellulitis lower right leg | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Sprained right ankle | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Sinus infection | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Kidneys infection | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gout | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Felt very tired | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Back pain from arthritis | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Gout flare-up | 0/59 (0%) | 1/59 (1.7%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
| Urinary tract infection | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Boil on vaginal area | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Chest pains | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Worsening of acid reflux | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Mycosis fungoides of the skin | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Seasonal allergies | 0/59 (0%) | 0/59 (0%) | 1/58 (1.7%) | 0/58 (0%) | 0/60 (0%) | |||||
| Lower back pain | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Diverticulitis | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Sinus drainage | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Erythema facial | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Brown coating on tongue | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 1/60 (1.7%) | |||||
| Dizziness and vomiting | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Broke right hip (right intertrochanteric hip fracture) | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 1/58 (1.7%) | 0/60 (0%) | |||||
| Worsening of arthritis | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Left eye swollen and red beneath eye | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Stomach virus | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Right shoulder pain | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Infections and infestations | ||||||||||
| Infected tooth 10 | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Thermal burn anterior hard palate | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Crown come off tooth 9 | 0/59 (0%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 1/60 (1.7%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Sore throat left side | 1/59 (1.7%) | 0/59 (0%) | 0/58 (0%) | 0/58 (0%) | 0/60 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563172
Other Study ID Numbers:
- T3158587
First Posted:
Mar 26, 2012
Last Update Posted:
Feb 7, 2018
Last Verified:
Jan 1, 2018