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

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

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Key information

Conditions

White Spot Lesion

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Children aged 3 to 5 years, in good general health, and medically free.
Prescence of at least one WSL on anterior primary teeth with an ICDAS II score of one or two.
Cooperative patients who will comply with follow-ups.
Parents who accept to sign informed consent.

Exclusion criteria

Uncooperative children.
Children with a physical disability or medical disability.
Children with teeth that shows enamel hypoplasia.
Children that have received a fluoride supplement or professional topical fluoride application at least 3 months before the study.
Parents refuse to give written formed consent.

Treatment and study plan

Egg shell hydrogel

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

Drug

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

Primary outcomes

Remineralization potential.

Time frame: at 6th , 18 and 30th week

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 .

Secondary outcomes

Activity of the lesion

Time frame: will be assessed using Nyvad's criteria at 6th , 18 and 30th week

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 .
Oral hygiene

Time frame: at 6th , 18 and 30th week

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 .

Study contacts

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

sara B youssef, bachelor degree of dentistry

CONTACT

[email protected]

01118319830

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 17, 2025
Registry last updated: May 15, 2025

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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