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Not yet recruiting NCT06932926

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

Phase II Interventional White Spot Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Egg shell hydrogel, Fluoride varnish.
Who it may be relevant to
Registry conditions: White Spot Lesion. Basic parameters: 3 years — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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-size
  • Drug Fluoride varnish
    five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).

Primary outcome measures

  • Remineralization potential. [Time frame: at 6th , 18 and 30th week]
Secondary outcome measures (2)
  • Activity of the lesion [Time frame: will be assessed using Nyvad's criteria at 6th , 18 and 30th week]
  • Oral hygiene [Time frame: at 6th , 18 and 30th week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06932926 · Faculty of dentistry CairoU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗