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

Mansoura University90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Initial Dental Caries

Interventions

nano-eggshell varnish

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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