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| Name | Class |
|---|---|
| Department of Integrated Dentistry Medical University of Białystok | UNKNOWN |
| Poznan University of Medical Sciences, Department of Integrated Dentistry | UNKNOWN |
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The aim of the study is to compare the caries-preventive effect of the test and control toothpaste in order to proof the non-inferiority of the test toothpaste compared to the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Calcium Hypophosphite Toothpaste | Experimental |
| |
| Sodium Fluoride Toothpaste (1450 ppm F) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Calcium Hypophosphite Toothpaste | Device | Oral hygiene instruction and regular application of the 2% Calcium Hypophosphite Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index | Comparison between the 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects showing no increase in overall Decay-Missing-Filled index during the observation period of 546 days (assessed by the investigator). | Day 1, Day 182±28, Day 365±28 vs. Day 546±28 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions | Comparison between 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects with no change in mineral density, as analyzed by DIAGNOcam Full Vision HD using near-infrared laser transillumination, over an observation period of 546 days (assessed by the investigator). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Enax, PhD | Contact | +49 521 8808 6064 | joachim.enax@drwolffgroup.com | |
| Clarissa Masur, PhD | Contact | +49 521 8808 319 | clarissa.masur@drwolffgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Elzbieta Paszynska, Prof., DDS, Msc, PhD | Poznan University of Medical Sciences | Principal Investigator |
| Malgorzata Pawinska, Assoc. Prof., DDS, PhD | Department of Integrated Dentistry Medical University of Białystok |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Integrated Dentistry Medical University of Białystok | Not yet recruiting | Bialystok | Poland | 15-276 | Poland |
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| Sodium Fluoride Toothpaste (1450 ppm F) | Device | Oral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months). |
|
| Day 1 vs. Day 546±28 |
| Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index | At the study visits, a suitable disclosing solution such as Bismarck Brown, Diaplac or similar is painted on tooth surfaces. After the subject has rinsed, the investigator (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction. After all teeth have been examined and scored, the index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces. Plaque Control Record Index Calculation = The number of plaque containing surfaces / The total number of available surfaces | Day 1, Day 182±28, Day 365±28 vs. Day 546±28 |
| Poznan University of Medical Sciences, Department of Integrated Dentistry | Recruiting | Poznan | Poland | 60-812 | Poland |
|
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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