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

NCT06932926 | Not Yet Recruiting Phase 2

• 1 other identifier: Faculty of dentistry CairoU
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Activity of the lesion

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

• Oral hygiene

  at 6th , 18 and 30th week

Study Arms (2)

Egg shell hydrogel.

EXPERIMENTAL

Drug: Egg shell hydrogel

Fluoride varnish.

ACTIVE COMPARATOR

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

Drug: Fluoride varnish

Interventions

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.

Egg shell hydrogel.

Fluoride varnish DRUG

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

Fluoride varnish.

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

sara B youssef, bachelor degree of dentistry

CONTACT

01118319830; sara.youssef@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05