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

ConditionInitial Dental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-20
SponsorMansoura University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: nano-eggshell varnish group 1Experimental treatment 1 intervention
Group B: Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2Experimental treatment 1 intervention
Group C: Sodium fluoride varnish (5%) group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 12 months
2

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

Time frame
Baseline, 3, 6, 9, and 12 months

Secondary outcomes

1

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

Time frame
Baseline, 3, 6, 9, and 12 months
2

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.

Time frame
baseline, after 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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