White Spot LesionNCT03391180
The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances
A study testing ICON Remineralization and CPP-ACPF in people with White Spot Lesion, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- ICON Remineralization and CPP-ACPF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2018to Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment.
Who cannot join
- Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, ArRiyadh, 11681
About this study
Official title: The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial
The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.
Read the detailed description
The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).
- Conditions
- White Spot Lesion
- Being tested
- ICON Remineralization, CPP-ACPF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICON RemineralizationDrug
A material used for the Remineralization of white spot lesions.
CPP-ACPFDrug
Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.
| Study group | Role | What they receive |
|---|---|---|
| ICON Remineralization | Experimental | Firstly, Conditioning of the WSL surface by 15% HCL gel (Icon-Etch, DNG) and subsequent application of the drying solution (Icon-Dry, DMG), Numbers of additional etching intervals have been determined by visual assessment after each of the etch/dry intervals to achieve individual, customized intensities of WSL surface conditioning. Receives: Drug: ICON Remineralization |
| CPP-ACPF | Active comparator | Participants in group 2 (CPP-ACPF) were treated with applying a pea sized amount of ACC-ACPF plus on a gloved finger of the examiner and rubbed the surface of the labial tooth for 4 minutes with advising the patient to avoid drinking and eating for the next 30 minutes of application. Receives: Drug: CPP-ACPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization
Using DIAGNOdent Laser device.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Omar H AlKadhi, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391180
- Sponsor's protocol ID
- FGR/2018/45
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03391180
- Acronym / sponsor ID
- FGR/2018/45
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 5 Jan 2018 (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.
The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.
Detailed description
The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICON Remineralization | Experimental | Drug: ICON RemineralizationFirstly, Conditioning of the WSL surface by 15% HCL gel (Icon-Etch, DNG) and subsequent application of the drying solution (Icon-Dry, DMG), Numbers of additional etching intervals have been determined by visual assessment after each of the etch/dry intervals to achieve individual, customized intensities of WSL surface conditioning. |
| CPP-ACPF | Active comparator | Drug: CPP-ACPFParticipants in group 2 (CPP-ACPF) were treated with applying a pea sized amount of ACC-ACPF plus on a gloved finger of the examiner and rubbed the surface of the labial tooth for 4 minutes with advising the patient to avoid drinking and eating for the next 30 minutes of application. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment.
Key exclusion criteria (1 listed)
- Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.
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 |
|---|---|---|
| ICON RemineralizationA material used for the Remineralization of white spot lesions. | Drug | ICON Remineralization |
| CPP-ACPFCasein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions. | Drug | CPP-ACPF |
Primary outcome
Remineralization
Time frame: 3 Months
Using DIAGNOdent Laser device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Omar H AlKadhi principal investigator
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICON Remineralization and CPP-ACPF in people with White Spot Lesion, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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: status not confirmed, as of the sponsor's last update on 5 Jan 2018. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar H AlKadhi, BDS, MS (966505154754, omar.alkadhi@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization (time frame: 3 Months). 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 5 Jan 2018.