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.

University Hospital, Ghent107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

107

Conditions

White Spot Lesion Orthodontic Appliance Complication

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.