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.

Not Applicable

Completed

• Conditions: White Spot Lesion; Orthodontic Appliance Complication
• Interventions: Other: CPP-ACPF paste; Other: 1.25% fluoride gel; Other: Conventional; Other: CPP-ACP paste

• Registration Number: NCT05710874
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-23
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-02
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPP-ACPF paste	CPP-ACPF paste	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	1.25% fluoride gel	Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Conventional	Conventional	Twice daily use of conventional toothpaste.
CPP-ACP paste	CPP-ACP paste	Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.

Primary Outcome Measures

Name	Time	Method
Evolution of the relative area of the white spot lesions	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.	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.
Evolution of the Andersson Index of the white spot lesions	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.	The Andersson Index (AI) was determined on the basis of the clinical pictures.

Secondary Outcome Measures

Name	Time	Method
Patient's use of the tooth paste	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.	According to the patient's use of toothpaste, a score 0 (hardly ever use toothpaste) or 1 (usually or always use toothpaste) is given.
Gingival Index	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.	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.
Plaque Index	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.	The Gingival Index is determined by the maximum score measured on the included teeth. Score 0 means no plaque and score 1 means plaque.

Trial Locations

Locations (1)

University of Ghent; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium