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NCT Number: NCT07711132

Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries

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.

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Key information

Conditions

Initial Dental Caries

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nano-eggshell varnish

Drug

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 Paste

Drug

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada E Elhindawy

CONTACT

[email protected]

00201102668577

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Remineralizing Effect of Nano-eggshell, Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP), and Sodium Fluoride on Initial Enamel Caries: Randomized Controlled Trial

Acronym: CPP-ACP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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