Initial Dental CariesCPP-ACPNCT07711132
Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries
A study testing nano-eggshell varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste and Sodium Fluoride Varnish (5%) in people with Initial Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years. Participants will be randomly allocated into three groups. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Initial Dental Caries
- What is being tested?
- nano-eggshell varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste and Sodium Fluoride Varnish (5%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-2. Patients should have moderate-to-high caries risk.
Who cannot join
- Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah
About this study
Official title: Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years.
Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
- Conditions
- Initial Dental Caries
- Being tested
- nano-eggshell varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste, Sodium Fluoride Varnish (5%)
- Keywords
- Remineralization, Nano eggshell, initial enamel caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano-eggshell varnishDrug
Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries.
Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental PasteDrug
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied daily by participants after tooth brushing at bedtime and left on teeth for at least 3 minutes before rinsing.
Sodium Fluoride Varnish (5%)Drug
5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent.
| Study group | Role | What they receive |
|---|---|---|
| nano-eggshell varnish group 1 | Experimental | Nano-eggshell varnish will be professionally applied to the teeth surfaces every 3 months according to the manufacturer's instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. Receives: Drug: nano-eggshell varnish |
| Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2 | Experimental | Participants will be instructed to apply CPP-ACP (GC tooth mousse) daily after tooth brushing at bedtime. The material will be kept on the tooth surfaces for at least 3 minutes before rinsing. Receives: Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste |
| Sodium fluoride varnish (5%) group 3 | Active comparator | Sodium fluoride varnish (5%) will be professionally applied every 3 months according to manufacturer instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. Receives: Drug: Sodium Fluoride Varnish (5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in remineralization of initial enamel caries
Change in remineralization of initial enamel caries measured by DIAGNOdent readings from baseline to 12 months. When the DIAGNOdent reading decreases, it means good remineralization ability.
Measured: Baseline to 12 months
Change in DIAGNOdent readings
The DIAGNOdent device will be used to quantify changes in enamel demineralization and remineralization over time. Measurements will be recorded at different follow-up intervals
Measured: Baseline, 3, 6, 9, and 12 months
Secondary outcomes (2)
Caries activity assessment using ICCMS criteria
Caries activity will be assessed using the International Caries Classification and Management System (ICCMS) criteria. Lesions will be classified as active or inactive based on surface texture, appearance, and plaque stagnation area
Measured: Baseline, 3, 6, 9, and 12 months
Change in the Decayed, Missing, and Filled Surfaces (DMFS) index
Dental caries experience will be evaluated using the Decayed, Missing, and Filled Surfaces (DMFS) index at baseline and after 6 and 12 months to assess overall changes in caries experience.
Measured: baseline, after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start20 Dec 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
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 Initial Dental CariesStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into three parallel groups. Each group will receive a different intervention: nano-eggshell varnish, sodium fluoride varnish (5%), or GC Tooth Mousse. The interventions will be applied according to the study protocol, and participants will be followed for 12 months to assess remineralization outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711132
- Sponsor's protocol ID
- M0409023PP
- Acronym
- CPP-ACP
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available upon request
Publications
Sarhan M, El Baz M, Hamza O. Remineralization effect of eggshell powder on post-orthodontic white spot lesions compared to CPP-ACP: a randomized controlled clinical trial. Egyptian Dental Journal. 2021. 67(3): 2701-2710.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07711132
- Acronym / sponsor ID
- CPP-ACP / M0409023PP
- Conditions
- Initial Dental Caries
- Keywords
- Remineralization, Nano eggshell, initial enamel caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 17 Jul 2026 (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 randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years.
Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned into three parallel groups. Each group will receive a different intervention: nano-eggshell varnish, sodium fluoride varnish (5%), or GC Tooth Mousse. The interventions will be applied according to the study protocol, and participants will be followed for 12 months to assess remineralization outcomes.
| Arm | Type | Receives |
|---|---|---|
| nano-eggshell varnish group 1 | Experimental | Drug: nano-eggshell varnishNano-eggshell varnish will be professionally applied to the teeth surfaces every 3 months according to the manufacturer's instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. |
| Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2 | Experimental | Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental PasteParticipants will be instructed to apply CPP-ACP (GC tooth mousse) daily after tooth brushing at bedtime. The material will be kept on the tooth surfaces for at least 3 minutes before rinsing. |
| Sodium fluoride varnish (5%) group 3 | Active comparator | Drug: Sodium Fluoride Varnish (5%)Sodium fluoride varnish (5%) will be professionally applied every 3 months according to manufacturer instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-2. Patients should have moderate-to-high caries risk.
Key exclusion criteria (1 listed)
- Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
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 |
|---|---|---|
| nano-eggshell varnishNano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries. | Drug | nano-eggshell varnish group 1 |
| Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental PasteCasein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied daily by participants after tooth brushing at bedtime and left on teeth for at least 3 minutes before rinsing. | Drug | Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2 |
| Sodium Fluoride Varnish (5%)5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent. | Drug | Sodium fluoride varnish (5%) group 3 |
Primary outcome
Change in remineralization of initial enamel caries
Time frame: Baseline to 12 months
Change in remineralization of initial enamel caries measured by DIAGNOdent readings from baseline to 12 months. When the DIAGNOdent reading decreases, it means good remineralization ability.
Change in DIAGNOdent readings
Time frame: Baseline, 3, 6, 9, and 12 months
The DIAGNOdent device will be used to quantify changes in enamel demineralization and remineralization over time. Measurements will be recorded at different follow-up intervals
2 secondary outcomes
Caries activity assessment using ICCMS criteria
Time frame: Baseline, 3, 6, 9, and 12 months
Change in the Decayed, Missing, and Filled Surfaces (DMFS) index
Time frame: baseline, after 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- BackgroundSarhan M, El Baz M, Hamza O. Remineralization effect of eggshell powder on post-orthodontic white spot lesions compared to CPP-ACP: a randomized controlled clinical trial. Egyptian Dental Journal. 2021. 67(3): 2701-2710.
- Individual participant dataSharing planned: Yes. Data available upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nano-eggshell varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste and Sodium Fluoride Varnish (5%) in people with Initial Dental Caries, run by Mansoura 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 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada E Elhindawy (00201102668577, ghada.ezzat91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in remineralization of initial enamel caries (time frame: Baseline to 12 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?
On the ClinicalTrials.gov record for NCT07711132, 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 17 Jul 2026.