Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.
Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.
Materials and methods: This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia) | Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ola Al-Batayneh, MDSc, FRACDS | Associate Professor in Pediatric Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | 22110 | Jordan |
The data will be shared as in demographics of the study sample.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005459 | Fluorides |
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
Not provided
Not provided
This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.
Not provided
Not provided
Not provided
Not provided
| 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 tooth brushing, 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 |