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The goal of this randomized clinical trial is to compare the influence of casein phosphopeptide amorphous calcium phosphate (CPP-ACP), CPP-ACP in combination with fluoride (CPP-ACPF), high fluoride concentration, and conventional fluoride toothpaste on the color and size of white spot lesions (WSLs) in orthodontic patients following bracket removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPP-ACP paste | Experimental | Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste. |
|
| CPP-ACPF paste | Experimental | Daily application of CPP-ACPF (Casein phosphopeptide amorphous calcium phosphate in combination with fluoride) paste (MI Paste Plus®) in addition to twice daily use of conventional toothpaste.. |
|
| 1.25% fluoride gel | Experimental | Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste. |
|
| Conventional | Placebo Comparator | Twice daily use of conventional toothpaste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPP-ACP paste | Other | Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the relative area of the white spot lesions | ImageJ® (National Institutes of Health, Bethesda, MD, USA) was used to measure the relative area. In order to measure the relative area of the white spot lesions, the affected tooth was trimmed out of the original photo and the entire buccal surface was measured in absolute pixels. After this, the white spot lesion was outlined and measured in pixels. | The change in relative area between the end of orthodontic treatment (T0) and 2 months after the end of orthodontic treatment (T1) is measured. |
| Evolution of the relative area of the white spot lesions | ImageJ® (National Institutes of Health, Bethesda, MD, USA) was used to measure the relative area. In order to measure the relative area of the white spot lesions, the affected tooth was trimmed out of the original photo and the entire buccal surface was measured in absolute pixels. After this, the white spot lesion was outlined and measured in pixels. | The change in relative area between the end of orthodontic treatment (T0) and 4 months after the end of orthodontic treatment (T2) is measured. Patients participate in the study for 4 months. |
| Evolution of the Andersson Index of the white spot lesions | The Andersson Index (AI) was determined on the basis of the clinical pictures. | The change in Andersson Index between the end of orthodontic treatment (T0) and 2 months after the end of orthodontic treatment (T1) is measured. |
| Evolution of the Andersson Index of the white spot lesions | The Andersson Index (AI) was determined on the basis of the clinical pictures. | The change in Andersson Index between the end of orthodontic treatment (T0) and 4 months after the end of orthodontic treatment (T2) is measured. Patients participate in the study for 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index | The Gingival Index is determined by the maximum score measured on the included teeth. Score 0 means no gingival inflammation and score 1 means gingival inflammation. | The Gingival Indexis measured at the end of orthodontic treatment (T0), at 2 months after the end of orthodontic treatment (T1) and at 4 months after the end of orthodontic treatment (T2). Patients participate in the study for 4 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Levine Gavel | Postgraduate Orthodontics | Principal Investigator |
| Valentina Elena Arevalo Cabrera | Master Student Oral Health Sciences | Principal Investigator |
| Deseyne Thomas | Alumnus Orthodontics | Principal Investigator |
| Guy AM De Pauw | Professor dr. in Orthodontics | Study Chair |
| Noëmi MC De Roo | Doctorate in Orthodontics | Study Chair |
| Liesbeth Temmerman | dr. in Orthodontics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ghent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| CPP-ACPF paste | Other | Daily application of CPP-ACPF (Casein phosphopeptide amorphous calcium phosphate in combination with fluoridepaste) (MI Paste Plus®) in addition to twice daily use of conventional toothpaste. |
|
| 1.25% fluoride gel | Other | Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste. |
|
| Conventional | Other | Twice daily use of conventional toothpaste. |
|
| Plaque Index | The Gingival Index is determined by the maximum score measured on the included teeth. Score 0 means no plaque and score 1 means plaque. | The Plaque Index is measured at the end of orthodontic treatment (T0), at 2 months after the end of orthodontic treatment (T1) and at 4 months after the end of orthodontic treatment (T2). Patients participate in the study for 4 months. |
| Patient's use of the tooth paste | According to the patient's use of toothpaste, a score 0 (hardly ever use toothpaste) or 1 (usually or always use toothpaste) is given. | The patient's use of the tooth paste is determined at 2 months after the end of orthodontic treatment (T1) and at 4 months after the end of orthodontic treatment (T2). Patients participate in the study for 4 months. |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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