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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental dentifrice 0.5g, 45 seconds brushing group | Experimental | Participants brush twice a daily for 45 seconds with experimental dentifrice. |
|
| Experimental dentifrice 1.5g, 45 seconds brushing group | Experimental | Participants brush twice a daily for 45 seconds with experimental dentifrice. |
|
| Experimental dentifrice 0.5g, 2 minutes brushing group | Experimental | Participants brush twice a daily for 2 minutes with experimental dentifrice. |
|
| Experimental dentifrice 1.5g, 2 minutes brushing group | Experimental | Participants brush twice a daily for 2 minutes with experimental dentifrice. |
|
| Contol group | Active Comparator | Participants brush twice a daily for 2 minutes with controll dentifrice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride / silica and carbopol, 0.5g | Drug | Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 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. | At Baseline and at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 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. |
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Inclusion Criteria:
General and Dental Health
Dentures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1 | ||
| 27717756 | Derived | Creeth JE, Kelly SA, Gonzalez-Cabezas C, Karwal R, Martinez-Mier EA, Lynch RJM, Bosma ML, Zero DT. Effect of toothbrushing duration and dentifrice quantity on enamel remineralisation: An in situ randomized clinical trial. J Dent. 2016 Dec;55:61-67. doi: 10.1016/j.jdent.2016.10.003. Epub 2016 Oct 4. |
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Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures.
Participants were recruited from 1 center in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: The overall Safety Population included all the participants who were randomized and used at least one of the treatment dentifrices during the study and had at least one safety assessment (e.g. assessment of adverse events [AEs] or had an oral soft tissue examination) after using the treatment dentifrices.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 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. | 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. | Posted | Least Squares Mean | Standard Error | % SMH | At Baseline and at Day 14 |
|
Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Not provided
| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| D012822 | Silicon Dioxide |
| C006912 | carboxypolymethylene |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Sodium fluoride / silica and carbopol, 1.5g | Drug | Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol |
|
| Sodium fluoride / silica and carbopol, 1.5g | Drug | Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol |
|
| Fluoride free dentifrice | Other | A non fluoride dentifrice was given to participants of each arm at washout period |
|
| At Baseline and at Day 14 |
| 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. | 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. | At Baseline and at Day 14 |
| 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. | 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. | At Baseline and at Day 14 |
| 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. | 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. | At Baseline and at Day 14 |
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 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. | At Day 14 |
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 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. | At Day 14 |
| 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. | 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. | At Day 14 |
| 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. | 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. | At Day 14 |
| 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. | 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. | At Day 14 |
| Other (Not specified) |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG000 | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. |
| OG001 | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. |
|
|
|
| Secondary | Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 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. | 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. | Posted | Least Squares Mean | Standard Error | % SMH | At Baseline and at Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | % SMH | At Baseline and at Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | % SMH | At Baseline and at Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | % SMH | At Baseline and at Day 14 |
|
|
|
|
| Secondary | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 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. | 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. | Posted | Least Squares Mean | Standard Error | micrograms (μg)×F/centimeters(cm)2 | At Day 14 |
|
|
|
|
| Secondary | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 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. | 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. | Posted | Least Squares Mean | Standard Error | μg×F/cm2 | At Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | μg×F/cm2 | At Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | μg×F/cm2 | At Day 14 |
|
|
|
|
| Secondary | 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. | 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. | 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. | Posted | Least Squares Mean | Standard Error | μg×F/cm2 | At Day 14 |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 11 |
| 59 |
| EG001 | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. | 0 | 59 | 0 | 59 | 8 | 59 |
| EG002 | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. | 0 | 58 | 0 | 58 | 12 | 58 |
| EG003 | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. | 0 | 58 | 0 | 58 | 10 | 58 |
| EG004 | Contol Group | Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice. | 0 | 60 | 0 | 60 | 10 | 60 |
| Common cold | General disorders | Systematic Assessment |
|
| Cellulitis lower right leg | General disorders | Systematic Assessment |
|
| Sore throat left side | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sprained right ankle | General disorders | Systematic Assessment |
|
| Sinus infection | General disorders | Systematic Assessment |
|
| Kidneys infection | General disorders | Systematic Assessment |
|
| Erythema anterior hard palate | Gastrointestinal disorders | Systematic Assessment |
|
| Gout | General disorders | Systematic Assessment |
|
| Gingival mucosa edentulous maxillary anterior ridge erythema | Gastrointestinal disorders | Systematic Assessment |
|
| Swelling of right inside of mouth & lip caused by biting | Gastrointestinal disorders | Systematic Assessment |
|
| Felt very tired | General disorders | Systematic Assessment |
|
| Ulceration on gingival lingual 26 ~2mm (millimeter) | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival mucosa cervical lingual area swollen with exudate | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain from arthritis | General disorders | Systematic Assessment |
|
| Gout flare-up | General disorders | Systematic Assessment |
|
| Gingival mucosa erythema of right posterior edentulous ridge | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival mucosa erythema left posterior edentulous ridge | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary tract infection | General disorders | Systematic Assessment |
|
| Boil on vaginal area | General disorders | Systematic Assessment |
|
| White coating on tongue | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pains | General disorders | Systematic Assessment |
|
| Worsening of acid reflux | General disorders | Systematic Assessment |
|
| Mycosis fungoides of the skin | General disorders | Systematic Assessment |
|
| Sore area on ridge area #22 from partial | Gastrointestinal disorders | Systematic Assessment |
|
| Submandibular area small ulcer not painful | Gastrointestinal disorders | Systematic Assessment |
|
| Seasonal allergies | General disorders | Systematic Assessment |
|
| Lower back pain | General disorders | Systematic Assessment |
|
| Diverticulitis | General disorders | Systematic Assessment |
|
| Sinus drainage | General disorders | Systematic Assessment |
|
| Erythema facial | General disorders | Systematic Assessment |
|
| Brown coating on tongue | General disorders | Systematic Assessment |
|
| Gingival mucosa erythema lingual tooth 23 | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness and vomiting | General disorders | Systematic Assessment |
|
| Broke right hip (right intertrochanteric hip fracture) | General disorders | Systematic Assessment |
|
| Worsening of arthritis | General disorders | Systematic Assessment |
|
| Thermal burn anterior hard palate | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infected tooth 10 | Infections and infestations | Systematic Assessment |
|
| Left eye swollen and red beneath eye | General disorders | Systematic Assessment |
|
| Stomach virus | General disorders | Systematic Assessment |
|
| Labial mucosa chapped lips upper & lower | Gastrointestinal disorders | Systematic Assessment |
|
| Crown come off tooth 9 | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Right shoulder pain | General disorders | Systematic Assessment |
|
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.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008903 | Minerals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |