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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06932926
Enrollment
66
Registered
2025-04-17
Start date
2025-09-30
Completion date
2026-03-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

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

Interventions

DRUGEgg 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.

DRUGFluoride varnish

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Remineralization potential.at 6th , 18 and 30th weekchange 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

MeasureTime frameDescription
Activity of the lesionwill be assessed using Nyvad's criteria at 6th , 18 and 30th weekwhether 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 hygieneat 6th , 18 and 30th weekOral 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 .

Contacts

Primary Contactsara B youssef, bachelor degree of dentistry
sara.youssef@dentistry.cu.edu.eg01118319830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026