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.
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2016
CompletedFirst Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2023
CompletedAugust 24, 2023
August 1, 2023
6.5 years
January 11, 2023
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
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.
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.
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.
Study Arms (4)
CPP-ACP paste
EXPERIMENTALDaily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.
CPP-ACPF paste
EXPERIMENTALDaily 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
EXPERIMENTALWeekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Conventional
PLACEBO COMPARATORTwice daily use of conventional toothpaste.
Interventions
Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.
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.
Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients were excluded from the study if enamel demineralization was already present before orthodontic treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ghent
Ghent, Oost-Vlaanderen, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Levine Gavel
Postgraduate Orthodontics
- PRINCIPAL INVESTIGATOR
Valentina Elena Arevalo Cabrera
Master Student Oral Health Sciences
- PRINCIPAL INVESTIGATOR
Deseyne Thomas
Alumnus Orthodontics
- STUDY CHAIR
Guy AM De Pauw
Professor dr. in Orthodontics
- STUDY CHAIR
Noëmi MC De Roo
Doctorate in Orthodontics
- STUDY CHAIR
Liesbeth Temmerman
dr. in Orthodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
February 2, 2023
Study Start
September 23, 2016
Primary Completion
March 29, 2023
Study Completion
March 29, 2023
Last Updated
August 24, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share