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In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSP/SMFP Dentifrice | Experimental | Dentifrice containing high fluoride content as SMFP and CSP |
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| SMFP Dentifrice Prototype 1 | Active Comparator | Dentifrice containing high fluoride content as SMFP and no CSP |
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| SMFP Dentifrice Prototype 2 | Active Comparator | Dentifrice containing low fluoride content as SMFP and no CSP |
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| CSP Dentifrice | Active Comparator | Dentifrice containing CSP but no fluoride |
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| Placebo Dentifrice | Placebo Comparator | Dentifrice containing no CSP and no fluoride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium sodium phosphosilicate | Drug | CSP high percentage weight by weight |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. | Baseline to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. |
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Inclusion 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 |
A total of 95 participants were screened, of which 79 were randomized. Of the subjects who were not randomized, 11 did not meet the study criteria; 3 had protocol violations; 2 withdrew consent.
Participants were recruited at one clinical site (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were evaluated for baseline characteristics. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. | PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. | Mean | Standard Error | Percentage SMHR | Baseline to 21 days |
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Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
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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 | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive lobular carcinoma of left breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival erythema | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| Sodium monoflurophosphate | Drug | 500 to 1500 parts per million (ppm) of fluoride |
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| Placebo | Drug | No CSP and no fluoride |
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| Baseline to 21 days |
| Enamel Fluoride Uptake (EFU) | Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens. | Baseline to 21 days |
| Other Reason |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. |
| OG002 | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. |
|
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| Secondary | Enamel Fluoride Uptake (EFU) | Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens. | PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group. | Mean | Standard Error | ppm EFU | Baseline to 21 days |
|
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| Primary | Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. | Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. | Mean | Standard Error | Percentage SMHR | Baseline to 21 days |
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| 1 |
| 75 |
| 18 |
| 75 |
| EG001 | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. | 0 | 71 | 13 | 71 |
| EG002 | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. | 2 | 70 | 14 | 70 |
| EG003 | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. | 0 | 69 | 11 | 69 |
| EG004 | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute. | 0 | 71 | 13 | 71 |
| Unstable angina pectoris | Cardiac disorders | Systematic Assessment |
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| Multiple myeloma of bones | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Oral mucosal exfoliation | Gastrointestinal disorders | Systematic Assessment |
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| Dental caries | General disorders | Systematic Assessment |
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| Gingival inflammation | Gastrointestinal disorders | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
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| Glossitis | Gastrointestinal disorders | Systematic Assessment |
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| Lip blister | Gastrointestinal disorders | Systematic Assessment |
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| Loose tooth | Gastrointestinal disorders | Systematic Assessment |
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| Sensitivity of teeth | Gastrointestinal disorders | Systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Tooth deposit | Gastrointestinal disorders | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
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| Herpes zoster | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
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| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Gingival injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gingival ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Amnesia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Oral fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Tooth repair | Surgical and medical procedures | Systematic Assessment |
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| Nodule | General disorders | Systematic Assessment |
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| Blood cholesterol increased | Investigations | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Eyelid irritation | Eye disorders | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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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.
The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be <= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice. |