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| Name | Class |
|---|---|
| Scientific Research Fund, Ministry of Higher Education and Research, Jordan | UNKNOWN |
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This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Materials and Methods:
o Study design:
The present study is a randomized control trial (RCT).
Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
Study procedure:
Group 1: children will brush their teeth with CPP-ACP twice daily.
Group 2: children will brush their teeth with fluoridated toothpaste twice daily.
Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPP-ACP paste | Active Comparator | Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein. |
|
| Fluoride toothpaste | Active Comparator | Fluoride toothpaste |
|
| Both (Fluoride and CPP-ACP) | Active Comparator | Fluoride toothpaste and CPP-ACP paste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPP-ACP paste | Other | Children will brush their teeth with CPP-ACP paste twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine | Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months. | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index. | Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months. | 3 and 6 months |
| Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ola Al-Batayneh, MDSc, FRACDS | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | 22110 | Jordan |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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This study is a randomized controlled trial involving 118 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. Children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoridated toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Quantitative assessment of white spot lesions will be carried out using QLF before remineralizing agent application (baseline) and at 3, and 6 month intervals.
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| Fluoride toothpaste |
| Other |
Children will brush their teeth with fluoridated toothpaste twice daily |
|
| Both (Fluoride and CPP-ACP) | Other | Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily. |
|
Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months. |
| 3 and 6 months |
| Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores. | Changes in ICDAS scores over 3 and 6 months. | 3 and 6 months |
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |