Early Caries LesionsNCT00670618
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
A study testing CPP-ACP (GC Tooth Mousse), CPP-ACP (GC MI Paste Plus) and Fluoride (Elmex Medical Gel) in people with Early Caries Lesions, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Early Caries Lesions
- What is being tested?
- CPP-ACP (GC Tooth Mousse), CPP-ACP (GC MI Paste Plus) and Fluoride (Elmex Medical Gel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2008to 26 Apr 2011
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- No white spot lesion at the time of placement of fixed appliances
Who cannot join
- White spots already present before start orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.
- Conditions
- Early Caries Lesions
- Being tested
- CPP-ACP (GC Tooth Mousse), CPP-ACP (GC MI Paste Plus), Fluoride (Elmex Medical Gel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-ACP (GC Tooth Mousse)Device
Calcium and phosphate
CPP-ACP (GC MI Paste Plus)Device
Calcium, phosphate and fluoride
Fluoride (Elmex Medical Gel)Device
Fluoride
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CPP-ACP (GC Tooth Mousse) Receives: Device: CPP-ACP (GC Tooth Mousse) |
| 2 | Experimental | GCC-ACP (GC MI Paste Plus) Receives: Device: CPP-ACP (GC MI Paste Plus) |
| 3 | Experimental | Fluoride (Elmex Medical Gel) Receives: Device: Fluoride (Elmex Medical Gel) |
| 4 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of the opacity of white spots during orthodontic treatment with fixed appliances
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study start1 Oct 2008
- Primary completion21 Jan 2011
- Study completion26 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Caries LesionsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- GC Europe
- Responsible party
- Sponsor
- Investigators
- Guy De Pauw, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670618
- Sponsor's protocol ID
- 2008/187 - Part 2
- Status last verified
- May 2023
- First submitted
- 30 Apr 2008
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 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 CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
- ClinicalTrials.gov ID
- NCT00670618
- Acronym / sponsor ID
- 2008/187 - Part 2
- Conditions
- Early Caries Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- GC Europe
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 21 Jan 2011 (actual)
- Study completion
- 26 Apr 2011 (actual)
- First posted
- 2 May 2008 (estimated)
- 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.
Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CPP-ACP (GC Tooth Mousse)CPP-ACP (GC Tooth Mousse) |
| 2 | Experimental | Device: CPP-ACP (GC MI Paste Plus)GCC-ACP (GC MI Paste Plus) |
| 3 | Experimental | Device: Fluoride (Elmex Medical Gel)Fluoride (Elmex Medical Gel) |
| 4 | No intervention | –Control group |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- No white spot lesion at the time of placement of fixed appliances
Key exclusion criteria (1 listed)
- White spots already present before start 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 (GC Tooth Mousse)Calcium and phosphate | Device | 1 |
| CPP-ACP (GC MI Paste Plus)Calcium, phosphate and fluoride | Device | 2 |
| Fluoride (Elmex Medical Gel)Fluoride | Device | 3 |
Primary outcome
Prevention of the opacity of white spots during orthodontic treatment with fixed appliances
Time frame: After 2 years
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 9 May 2023.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Early Caries Lesions
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Not yet recruitingPhase 2
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Demineralization, Tooth, 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.
Guy De Pauw, MD, PhD principal investigator
University Hospital, Ghent
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 (GC Tooth Mousse), CPP-ACP (GC MI Paste Plus) and Fluoride (Elmex Medical Gel) in people with Early Caries Lesions, 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 9 May 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. 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?
Prevention of the opacity of white spots during orthodontic treatment with fixed appliances (time frame: After 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.