Clinical trial NCT05710874: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Orthodontic Appliance Complication
Keywords: orthodontics
orthodontic brackets
dental caries
decalcification
caseins
fluorides
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 107
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of the relative area of the white spot lesions
timeFrame: The change in relative area between the end of orthodontic treatment (T0) and 2 months after the end of orthodontic treatment (T1) is measured.
measure: Evolution of the relative area of the white spot lesions
timeFrame: 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.
measure: Evolution of the Andersson Index of the white spot lesions
timeFrame: The change in Andersson Index between the end of orthodontic treatment (T0) and 2 months after the end of orthodontic treatment (T1) is measured.
measure: Evolution of the Andersson Index of the white spot lesions
timeFrame: 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:
measure: Gingival Index
timeFrame: 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.
measure: Plaque Index
timeFrame: 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.
measure: Patient's use of the tooth paste
timeFrame: 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.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University of Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: Postgraduate Orthodontics
name: Levine Gavel
role: PRINCIPAL_INVESTIGATOR
affiliation: Master Student Oral Health Sciences
name: Valentina Elena Arevalo Cabrera
role: PRINCIPAL_INVESTIGATOR
affiliation: Alumnus Orthodontics
name: Deseyne Thomas
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor dr. in Orthodontics
name: Guy AM De Pauw
role: STUDY_CHAIR
affiliation: Doctorate in Orthodontics
name: Noëmi MC De Roo
role: STUDY_CHAIR
affiliation: dr. in Orthodontics
name: Liesbeth Temmerman
role: STUDY_CHAIR
References: