White Spot LesionEarly Phase 1NCT06566833
Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth
A Early Phase 1 study testing self assmbling peptide p11-4 combined with 0.05% fluoride, Casein phosphopeptide amorphous calcium phosphate and 5% sodium fluoride varnish in people with White Spot Lesion, run by Alexandria University at 1 site in Egypt.
Trial summary
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- self assmbling peptide p11-4 combined with 0.05% fluoride, Casein phosphopeptide amorphous calcium phosphate and 5% sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 15 Oct 2024
- Phase
- Early 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
- age range 3-6
- at least 2 early carious lesions
Who cannot join
- Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
- Application of fluoride varnish less than 3 months prior to study treatment.
- Any metabolic disorders affecting bone turnover.
- Concurrent participation in another clinical trial.
- Patients receiving any antibiotic within 1 month prior to plaque sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.
Read the detailed description
The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.
- Conditions
- White Spot Lesion
- Being tested
- self assmbling peptide p11-4 combined with 0.05% fluoride, Casein phosphopeptide amorphous calcium phosphate, 5% sodium fluoride varnish
- Keywords
- curodont repair fluoride plus, CPP-ACPF, sodium fluoride varnish, guided enamel regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self assmbling peptide p11-4 combined with 0.05% fluorideDrug
Also called SAP P11-4
biomimetic remineralizing agent
Casein phosphopeptide amorphous calcium phosphateDrug
Also called CPP-ACPF
remineralizing agents that acts as a fluoride booster
5% sodium fluoride varnishDrug
Also called 5% NaF
remineralizing agent that is used as a gold standard for remineralization
| Study group | Role | What they receive |
|---|---|---|
| curodont repair fluoride plus | Experimental | self-assembling peptide (p11-4) with 0.05% sodium fluoride Receives: Drug: self assmbling peptide p11-4 combined with 0.05% fluoride |
| CPP-ACPF varnish | Experimental | casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF ) Receives: Drug: Casein phosphopeptide amorphous calcium phosphate |
| 5 % sodium fluoride varnish | Active comparator | 5% sodium fluoride varnish Receives: Drug: 5% sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the remineralization of early carious lesions in primary teeth
comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents
Measured: 3,6,9 and12 months
Secondary outcomes (2)
comparing the change in esthetic appearance of early carious lesion before and after treatment
comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7
Measured: 12 months
comparing the antibacterial effect of different remineralizing agents against streptococcus mutans
Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates
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 posted22 Aug 2024
- Study start15 Aug 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Khairy, Alexandria University
- Investigators
- karin dowidar, professor, Study director, faculty of Dentistry, Alexandria university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566833
- Sponsor's protocol ID
- 00010556 - IORG 0008839
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: only the results of the primary and secondary outcomes of the study will be published after study completion
Publications
Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23.
PubMed 33662244
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06566833
- Acronym / sponsor ID
- 00010556 - IORG 0008839
- Conditions
- White Spot Lesion
- Keywords
- curodont repair fluoride plus, CPP-ACPF, sodium fluoride varnish, guided enamel regeneration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 22 Aug 2024 (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 primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.
Detailed description
The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| curodont repair fluoride plus | Experimental | Drug: self assmbling peptide p11-4 combined with 0.05% fluorideself-assembling peptide (p11-4) with 0.05% sodium fluoride |
| CPP-ACPF varnish | Experimental | Drug: Casein phosphopeptide amorphous calcium phosphatecasein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF ) |
| 5 % sodium fluoride varnish | Active comparator | Drug: 5% sodium fluoride varnish5% sodium fluoride varnish |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy children
- age range 3-6
- at least 2 early carious lesions
Key exclusion criteria (5 listed)
- Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
- Application of fluoride varnish less than 3 months prior to study treatment.
- Any metabolic disorders affecting bone turnover.
- Concurrent participation in another clinical trial.
- Patients receiving any antibiotic within 1 month prior to plaque sample collection
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 |
|---|---|---|
| self assmbling peptide p11-4 combined with 0.05% fluorideAlso: SAP P11-4biomimetic remineralizing agent | Drug | curodont repair fluoride plus |
| Casein phosphopeptide amorphous calcium phosphateAlso: CPP-ACPFremineralizing agents that acts as a fluoride booster | Drug | CPP-ACPF varnish |
| 5% sodium fluoride varnishAlso: 5% NaFremineralizing agent that is used as a gold standard for remineralization | Drug | 5 % sodium fluoride varnish |
Primary outcome
Assessing the remineralization of early carious lesions in primary teeth
Time frame: 3,6,9 and12 months
comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents
2 secondary outcomes
comparing the change in esthetic appearance of early carious lesion before and after treatment
Time frame: 12 months
comparing the antibacterial effect of different remineralizing agents against streptococcus mutans
Time frame: 3 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 29 Jan 2025.
- Background: PubMed 33662244Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23.
- Individual participant dataSharing planned: No. only the results of the primary and secondary outcomes of the study will be published after study completion
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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.
karin dowidar, professor study director
faculty of Dentistry, Alexandria university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing self assmbling peptide p11-4 combined with 0.05% fluoride, Casein phosphopeptide amorphous calcium phosphate and 5% sodium fluoride varnish in people with White Spot Lesion, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 5 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 29 Jan 2025. 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessing the remineralization of early carious lesions in primary teeth (time frame: 3,6,9 and12 months). 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 NCT06566833, which also lists 1 linked publication.
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 29 Jan 2025.