White Spot LesionNCT05710874

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.

A study testing CPP-ACP paste, CPP-ACPF paste and 1.25% fluoride gel in people with White Spot Lesion and Orthodontic Appliance Complication, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 to 60 yearsHealthy volunteers can take part
Conditions the study is for: White Spot Lesion, Orthodontic Appliance Complication
What is being tested?: CPP-ACP paste, CPP-ACPF paste and 1.25% fluoride gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 1 siteBelgium
Study dates: 23 Sep 2016to 29 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

Patients were excluded from the study if enamel demineralization was already present before orthodontic treatment.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University of Ghent
Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

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.

Conditions: White Spot Lesion, Orthodontic Appliance Complication
Being tested: CPP-ACP paste, CPP-ACPF paste, 1.25% fluoride gel, Conventional
Keywords: orthodontics, orthodontic brackets, dental caries, decalcification, caseins, fluorides
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05710874
Study group	Role	What they receive
CPP-ACP paste	Experimental	Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste. Receives: Other: CPP-ACP paste
CPP-ACPF paste	Experimental	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.. Receives: Other: CPP-ACPF paste
1.25% fluoride gel	Experimental	Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste. Receives: Other: 1.25% fluoride gel
Conventional	Placebo comparator	Twice daily use of conventional toothpaste. Receives: Other: Conventional

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 Index is determined by the maximum score measured on the included teeth. Score 0 means no gingival inflammation and score 1 means gingival inflammation.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 201629 Mar 2023

First posted2 Feb 2023
Study start23 Sep 2016
Primary completion29 Mar 2023
Study completion29 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for White Spot LesionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05710874
Sponsor's protocol ID: BC-01938
Status last verified: Aug 2023
First submitted: 11 Jan 2023
Last updated: 24 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
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S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
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All White Spot Lesion trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05710874
Acronym / sponsor ID: BC-01938
Conditions: White Spot Lesion, Orthodontic Appliance Complication
Keywords: orthodontics, orthodontic brackets, dental caries, decalcification, caseins, fluorides
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Study start: 23 Sep 2016 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 29 Mar 2023 (actual)
First posted: 2 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CPP-ACP paste	Experimental	Other: CPP-ACP pasteDaily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.
CPP-ACPF paste	Experimental	Other: CPP-ACPF pasteDaily 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	Experimental	Other: 1.25% fluoride gelWeekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.
Conventional	Placebo comparator	Other: ConventionalTwice daily use of conventional toothpaste.

Who may qualify

Ages: 12 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Patients were excluded from the study if enamel demineralization was already present before orthodontic treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CPP-ACP pasteDaily 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
CPP-ACPF pasteDaily 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.	Other	CPP-ACPF paste
1.25% fluoride gelWeekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.	Other	1.25% fluoride gel
ConventionalTwice daily use of conventional toothpaste.	Other	Conventional

Primary outcome

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.
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.
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.
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.

3 secondary outcomes

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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
Individual participant dataSharing planned: No

Related trials for White Spot Lesion

Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
White Spot Lesion of Tooth

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Levine Gavel principal investigator

Postgraduate Orthodontics

Valentina Elena Arevalo Cabrera principal investigator

Master Student Oral Health Sciences

Deseyne Thomas principal investigator

Alumnus Orthodontics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CPP-ACP paste, CPP-ACPF paste and 1.25% fluoride gel in people with White Spot Lesion and Orthodontic Appliance Complication, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05710874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.