Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries (CPP-ACP)
July 14, 2026 updated by: Mansoura University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ghada E Elhindawy
- Phone Number: 00201102668577
- Email: ghada.ezzat91@yahoo.com
Study Locations
-
-
-
Al Mansurah, Egypt
- Recruiting
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nano-eggshell varnish group 1
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.
|
Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries.
|
|
Experimental: Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2
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.
|
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.
|
|
Active Comparator: Sodium fluoride varnish (5%) group 3
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.
|
5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 12 months
|
|
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
|
Baseline, 3, 6, 9, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caries activity assessment using ICCMS criteria
Time Frame: Baseline, 3, 6, 9, and 12 months
|
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
|
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
|
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.
|
baseline, after 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2025
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
May 21, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- M0409023PP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data available upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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