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The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR).
This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo dentifrice/Fluoride rinse | Experimental | Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride |
|
| Placebo dentifrice/No rinse | Placebo Comparator | Twice daily brushing with a non-fluoride (placebo) toothpaste |
|
| Fluoride dentifrice/No rinse | Active Comparator | Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride |
|
| Fluoride dentifrice/Fluoride rinse | Experimental | Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride free toothpaste | Drug | Brushing with fluoride free toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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. | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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 rehardening 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. |
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Inclusion Criteria:
Aged between 18 and 85 years inclusive
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
Currently living in the Indianapolis, Indiana area and has not had a professional fluoride treatment within 14 days of the first treatment visit
Currently wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange areas to accommodate two enamel specimens
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
Have a salivary flow rate in the range of normal values (un-stimulated whole saliva flow rate ≥ 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
A total of 80 participants were screened. Of the 80 participants, 62 were randomized and 53 completed the study.
Participants were recruited at one center in United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | In this cross-over study, participants were randomized to receive each of following treatments:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | All randomized participants were evaluated for baseline characteristics |
| 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 Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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 participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | Posted | Mean | Standard Deviation | % SMHR | Baseline to 14 days |
|
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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 | Placebo Dentifrice/Fluoride Rinse | Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMATEMESIS | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Fluoride toothpaste | Drug | Brushing with fluoride containing toothpaste |
|
| Fluoride mouthwash | Drug | Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm |
|
| Baseline to 14 days |
| Enamel Fluoride Uptake | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). | Baseline to 14 days |
| Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. | Baseline to Day14 |
| Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. | Baseline up to Day 14 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Placebo Dentifrice/Fluoride Rinse | Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride |
| OG001 | Placebo Dentifrice/No Rinse | Twice daily brushing with a non-fluoride (placebo) toothpaste |
|
|
|
| Secondary | Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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 rehardening 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. | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | Posted | Mean | Standard Deviation | % SMHR | Baseline to 14 days |
|
|
|
| Secondary | Enamel Fluoride Uptake | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | Posted | Mean | Standard Deviation | microgram per square centimeter(μg/cm^2) | Baseline to 14 days |
|
|
|
| Secondary | Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | Posted | Mean | Standard Deviation | microgram per mililitre(μg/mL ) | Baseline to Day14 |
|
|
|
| Secondary | Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | Posted | Mean | Standard Deviation | μg/mL | Baseline up to Day 14 |
|
|
|
| 1 |
| 60 |
| 15 |
| 60 |
| EG001 | Placebo Dentifrice/No Rinse | Twice daily brushing with a non-fluoride (placebo) toothpaste | 1 | 56 | 13 | 56 |
| EG002 | Fluoride Dentifrice/No Rinse | Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride | 0 | 59 | 18 | 59 |
| EG003 | Fluoride Dentifrice/Fluoride Rinse | Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride. | 1 | 57 | 17 | 57 |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Systematic Assessment |
|
| Tongue Geographic | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
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| Lip Dry | Gastrointestinal disorders | Systematic Assessment |
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| Oral Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | Systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival Erythema | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival Hypertrophy | Gastrointestinal disorders | Systematic Assessment |
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| Gingival Oedema | Gastrointestinal disorders | Systematic Assessment |
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| Gingival Ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Lip Ulceration | Gastrointestinal disorders | Systematic Assessment |
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| MOUTH HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
|
| MOUTH ULCERATION | Gastrointestinal disorders | Systematic Assessment |
|
| ORAL MUCOSAL ERYTHEMA | Gastrointestinal disorders | Systematic Assessment |
|
| TRAUMATIC OCCLUSION | Gastrointestinal disorders | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | Systematic Assessment |
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| SINUSITIS | Infections and infestations | Systematic Assessment |
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| MOUTH INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| TONGUE INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| ARTHROPOD BITE | Injury, poisoning and procedural complications | Systematic Assessment |
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| ARTHROPOD STING | Injury, poisoning and procedural complications | Systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | Systematic Assessment |
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| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | Systematic Assessment |
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| TRAUMATIC HAEMATOMA | Injury, poisoning and procedural complications | Systematic Assessment |
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| INJURY ASSOCIATED WITH DEVICE | General disorders | Systematic Assessment |
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| CHEST PAIN | General disorders | Systematic Assessment |
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| MEDICAL DEVICE PAIN | General disorders | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | Systematic Assessment |
|
| SMEAR CERVIX ABNORMAL | Investigations | Systematic Assessment |
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| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| THROAT TIGHTNESS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HYPERTENSION | Vascular 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.