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

Remineralization Potential Of Egg Shell Hydrogel Versus Fluoride Varnish On Early Carious White Spot Lesions In Anterior Primary Teeth: A Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: Egg shell hydrogel; Drug: Fluoride varnish

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: sara B youssef, bachelor degree of dentistry; Phone Number: 01118319830; Email: sara.youssef@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egg shell hydrogel.	Drug: 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.
Active Comparator: Fluoride varnish.; five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).	Drug: Fluoride varnish; five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization potential.	change in minerals content of the lesion , will be assessed using diagnodent scores ( minimum value is 0 and maximum value is 99 ) higher scores means worse outcome .	at 6th , 18 and 30th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of the lesion	whether the lesion is active or in active , will be assessed using Nyvad's criteria ( minimum value is score 0 and maximum value is score 9) higher scores means worse outcome .	will be assessed using Nyvad's criteria at 6th , 18 and 30th week
Oral hygiene	Oral hygiene status will be assessed using modification of OHI-S ( Simplified Oral Hygiene Index ) minimum value is score 0 and maximum value is score 3 higher score means worse outcome .	at 6th , 18 and 30th week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: Faculty of dentistry CairoU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No