White Spot LesionPhase 2NCT06932926
Remineralization Effect Of Egg Shell Versus Fluoride Varnish On Early Carious White Spot Lesions In Primary Teeth
A Phase 2 study testing Egg shell hydrogel and Fluoride varnish in people with White Spot Lesion, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Egg shell hydrogel and Fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Egg shell hydrogel, Fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg shell hydrogelDrug
- 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 varnishDrug
five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).
| Study group | Role | What they receive |
|---|---|---|
| Egg shell hydrogel. | Experimental | Not described Receives: Drug: Egg shell hydrogel |
| Fluoride varnish. | Active comparator | five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea). Receives: Drug: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: at 6th , 18 and 30th week
Secondary outcomes (2)
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 .
Measured: 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 .
Measured: at 6th , 18 and 30th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Bahr Hussein Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932926
- Sponsor's protocol ID
- Faculty of dentistry CairoU
- Status last verified
- May 2025
- First submitted
- 10 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06932926
- Acronym / sponsor ID
- Faculty of dentistry CairoU
- Conditions
- White Spot Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg shell hydrogel. | Experimental | Drug: Egg shell hydrogel |
| Fluoride varnish. | Active comparator | Drug: Fluoride varnishfive percent sodium fluoride varnish (Charm varnish -Dentkist- Korea). |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg shell hydrogelI. 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. | Drug | Egg shell hydrogel. |
| Fluoride varnishfive percent sodium fluoride varnish (Charm varnish -Dentkist- Korea). | Drug | Fluoride varnish. |
Primary outcome
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 .
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Egg shell hydrogel and Fluoride varnish in people with White Spot Lesion, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sara B youssef, bachelor degree of dentistry (01118319830, sara.youssef@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization potential. (time frame: at 6th , 18 and 30th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.