A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Clinical Study on the Effects of Casein Phosphopeptide Amorphous Calcium Phosphate Paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.

Conditions
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White Spot Lesion, Orthodontic Appliance Complication

Intervention / Treatment
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* Other: CPP-ACP paste
* Other: CPP-ACPF paste
* Other: 1.25% fluoride gel
* Other: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with fixed orthodontic appliances at the Ghent University Hospital who developed at least three WSLs at debonding were included. Informed consent had to be obtained from the patient, both verbally and written. Exclusion Criteria: Patients were excluded from the study if enamel demineralization was already present before orthodontic treatment.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPP-ACP paste<br>Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste. | Other: CPP-ACP paste<br>* Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.<br>|
| Experimental: CPP-ACPF paste<br>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.. | Other: CPP-ACPF paste<br>* 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.<br>|
| Experimental: 1.25% fluoride gel<br>Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste. | Other: 1.25% fluoride gel<br>* Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.<br>|
| Placebo Comparator: Conventional<br>Twice daily use of conventional toothpaste. | Other: Conventional<br>* Twice daily use of conventional toothpaste.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caseins, orthodontics, orthodontic brackets, dental caries, decalcification, fluorides