Remineralization Effect Of Egg Shell Versus Fluoride Varnish On Early Carious White Spot Lesions In Primary Teeth

NCT ID: NCT06932926

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-03-31

Brief Summary

The goal of this clinical trial is to to assess the remineralization potential of Egg shell hydrogel versus fluoride varnish in early carious white spot lesions in anterior primary teeth.

The main question it aims to answer is:What is the remineralization potential of egg shell hydrogel on early carious white spot lesions compared to fluoride varnish in anterior primary teeth? Researcher will compare egg shell hydrogel with fluoride varnish to see if it is able to promote lesion remineralization.

interventions that will be given to participasnts: egg shell hydrogel & five percent sodium fluoride varnish

Conditions

White Spot Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Egg shell hydrogel.

Group Type: EXPERIMENTAL

Egg shell hydrogel

Intervention Type: DRUG

I. Nano-eggshell powder preparation: After cleaning, A small crack will be made in each eggshell to split it into two halves to evacuate the content. The eggshells will be disinfected in a hot water at 100°C for 10 minutes to facilitate the detachment of the inner membrane. They will be exposed to steam sterilization. Then they will be crushed using a sterile mortar and pestle. The crushed particles will be milled using a zirconia ball-milling machine at 200 rpm . This will result in a nano-sized eggshell powder to incorporate them into a gel form.

II. Preparation of eggshell hydrogel formulations: through dispersing a suitable concentration of egg shell powder in distilled water, followed by dissolving the gelling agent; sodium carboxymethyl cellulose at a concentration of 5-10% under continuous stirring. The formed hydrogel will be kept at 8°C for a period of 24 hours before further use. This will produce a paste of consistency that is appropriate for handling and application.

Fluoride varnish.

five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).

Group Type: ACTIVE_COMPARATOR

Fluoride varnish

Intervention Type: DRUG

five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).

Interventions

Egg shell hydrogel

I. Nano-eggshell powder preparation: After cleaning, A small crack will be made in each eggshell to split it into two halves to evacuate the content. The eggshells will be disinfected in a hot water at 100°C for 10 minutes to facilitate the detachment of the inner membrane. They will be exposed to steam sterilization. Then they will be crushed using a sterile mortar and pestle. The crushed particles will be milled using a zirconia ball-milling machine at 200 rpm . This will result in a nano-sized eggshell powder to incorporate them into a gel form.

II. Preparation of eggshell hydrogel formulations: through dispersing a suitable concentration of egg shell powder in distilled water, followed by dissolving the gelling agent; sodium carboxymethyl cellulose at a concentration of 5-10% under continuous stirring. The formed hydrogel will be kept at 8°C for a period of 24 hours before further use. This will produce a paste of consistency that is appropriate for handling and application.

Intervention Type: DRUG

Fluoride varnish

five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Children aged 3 to 5 years, in good general health, and medically free.

2. Prescence of at least one WSL on anterior primary teeth with an ICDAS II score of one or two.

3. Cooperative patients who will comply with follow-ups.

4. Parents who accept to sign informed consent.

Exclusion Criteria

1. Uncooperative children.

2. Children with a physical disability or medical disability.

3. Children with teeth that shows enamel hypoplasia.

4. Children that have received a fluoride supplement or professional topical fluoride application at least 3 months before the study.

5. Parents refuse to give written formed consent.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Bahr Hussein Youssef

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

sara B youssef, bachelor degree of dentistry

Role: CONTACT

sara.youssef@dentistry.cu.edu.eg

01118319830

Other Identifiers

Faculty of dentistry CairoU

Identifier Type: -

Identifier Source: org_study_id