White Spot LesionPhase 1NCT03187548
Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment
A Phase 1 study testing Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste in people with White Spot Lesion and Enamel Hypomineralization, run by Cairo University.
Trial summary
This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion, Enamel Hypomineralization
- What is being tested?
- Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jan 2018
- Phase
- Phase 1
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- severe crowding
- Increased overjet
- Protruded maxillary base
- Sound maxillary premolars
- medically free
- molar classification class II
- Canine classification class II
Who cannot join
- spacing of teeth
- Decreased overjet
- Molar classification III Medically compromised patients
- pregnant females
- carious premolars
- hypoplasia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design
This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.
Read the detailed description
CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.
- Conditions
- White Spot Lesion, Enamel Hypomineralization
- Being tested
- Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste
- Keywords
- WSL, CPP-ACP
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein Phosphopeptide-Amorphous Calcium Phosphate Dental PasteDrug
Application of CPP-ACP on one premolar once every 2 weeks for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| CPP-ACP | Experimental | Casein phosphopeptide amorphous calcium phosphate dental paste Receives: Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on enamel surface color
Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II
Measured: 3 months
Effect on enamel surface
Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph
Measured: 3 mnths
Secondary outcomes (2)
Surface texture
Assessment of the effect of CPP-ACP on enamel surface texture using scanning electron microscope
Measured: 3 months
Microhardnes
Assessment of the effect of CPP-ACP on enamel microhardness using Vickers hardness test
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 posted15 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionJan 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.
- More trials run by Cairo UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abd El-Monem Nasr, Cairo University
- Investigators
- Maha Swelam, Bachelor, Principal investigator, Department of orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187548
- Sponsor's protocol ID
- CPP-ACP_whitespots
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design
- ClinicalTrials.gov ID
- NCT03187548
- Acronym / sponsor ID
- CPP-ACP_whitespots
- Conditions
- White Spot Lesion, Enamel Hypomineralization
- Keywords
- WSL, CPP-ACP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Jun 2017 (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.
This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.
Detailed description
CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPP-ACP | Experimental | Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental PasteCasein phosphopeptide amorphous calcium phosphate dental paste |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- severe crowding
- Increased overjet
- Protruded maxillary base
- Sound maxillary premolars
- medically free
Key exclusion criteria (6 listed)
- spacing of teeth
- Decreased overjet
- Molar classification III Medically compromised patients
- pregnant females
- carious premolars
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 |
|---|---|---|
| Casein Phosphopeptide-Amorphous Calcium Phosphate Dental PasteApplication of CPP-ACP on one premolar once every 2 weeks for 3 months. | Drug | CPP-ACP |
Primary outcome
Effect on enamel surface color
Time frame: 3 months
Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II
Effect on enamel surface
Time frame: 3 mnths
Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph
2 secondary outcomes
Surface texture
Time frame: 3 months
Microhardnes
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- 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.
Maha Swelam, Bachelor principal investigator
Department of orthodontics
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste in people with White Spot Lesion and Enamel Hypomineralization, run by Cairo University.
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 7 inclusion and 6 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fatma Abdou, Professor (01006739365, Fatmaabdou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on enamel surface color (time frame: 3 months). The study lists 2 primary outcomes in all. 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 15 Jun 2017.