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| ID | Type | Description | Link |
|---|---|---|---|
| D43TW007768 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.
CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tooth Mousse | Active Comparator | 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste |
|
| placebo control paste | Placebo Comparator | the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 % w/v CPP-ACP paste | Drug | Apply once a day at school by school teacher, following fluoride toothbrushing after lunch |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Mean Number of Enamel Carious Lesion | tooth surface that was classified as ICDAS code 1-3 | one calender year |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Light-induced Fluorescence (QLF) Parameters | percent fluorescence loss, lesion area, lesion volume | one calender year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thanya Sitthisettapong | Faculty of Dentistry, Thammasat University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Thammasat University | Klongluang | Patumthani | 12121 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22805294 | Derived | Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res. 2012 Sep;91(9):847-52. doi: 10.1177/0022034512454296. Epub 2012 Jul 17. |
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Six children were excluded from the study because they did not complete the inclusion criteria: autism (1), milk protein allergy (1), taking fluoride table (1), and no high caries risk (3).
The study took place in the central part of Thailand, where water [F]<0.1 ppm. The recruitment began in June 2010. There were 304 healthy Thai boys and girls from ten public nursery schools enrolled in the study. The baseline examination was performed at school in July-August, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tooth Mousse | 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste 10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch |
| FG001 | Placebo Control Paste | the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tooth Mousse | 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste 10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch |
| BG001 | Placebo Control Paste |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | the Mean Number of Enamel Carious Lesion | tooth surface that was classified as ICDAS code 1-3 | Posted | Mean | Standard Deviation | Surfaces | one calender year |
|
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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 | Tooth Mousse | 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste 10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch |
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This one year study was performed on high caries risk pre-school children who enrolled in government nursery schools in central part of Thailand.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thanya Sitthisettapong | ThammasatU | 6629869213 | 7150 | thanyasang@yahoo.com |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
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| the paste without CPP-ACP | Drug | Apply once a day at school by school teacher, following fluoride toothbrushing after lunch. |
|
the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Quantitative Light-induced Fluorescence (QLF) Parameters | percent fluorescence loss, lesion area, lesion volume | Not Posted | one calender year |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Placebo Control Paste | the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch. | 0 | 146 | 0 | 146 |
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