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.

August 23, 2023 updated by: University Hospital, Ghent

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • University of Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: 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..
Other: CPP-ACPF paste
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.
Experimental: 1.25% fluoride gel
Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Other: 1.25% fluoride gel
Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Placebo Comparator: Conventional
Twice daily use of conventional toothpaste.
Other: Conventional
Twice daily use of conventional toothpaste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 2 months after the end of orthodontic treatment (T1) is measured.
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
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.
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
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.
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
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.
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2016

Primary Completion (Actual)

March 29, 2023

Study Completion (Actual)

March 29, 2023

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-01938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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