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.

Ghent University Hospital (UZ)

Status: Completed

Conditions: Orthodontic Appliance Complication; White Spot Lesion

Treatments: Other: CPP-ACPF paste; Other: CPP-ACP paste; Other: Conventional; Other: 1.25% fluoride gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05710874

BC-01938

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 4 patient groups, including a placebo group

CPP-ACP paste

Experimental group

Description:

Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.

Treatment:

Other: CPP-ACP paste

CPP-ACPF paste

Experimental group

Description:

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..

Treatment:

Other: CPP-ACPF paste

1.25% fluoride gel

Experimental group

Description:

Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.

Treatment:

Other: 1.25% fluoride gel

Conventional

Placebo Comparator group

Description:

Twice daily use of conventional toothpaste.

Treatment:

Other: Conventional