White Spot LesionNCT07602660
Remineralization Potential of Bioactive Varnish
A study testing S-PRG barrier coat and Profluorid Varnish in people with White Spot Lesion, run by Future University in Egypt.
Trial summary
This randomized controlled trial is held to investigate the effectiveness of two remineralizing agents surface pre-reacted glass-ionomer (S-PRG) filler and fluoride in management of white spot lesions. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- S-PRG barrier coat and Profluorid Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients within 16-35 years of age.
- Each patient has 4 or more WSLs
- Mild and moderate WSLs.
- Good oral hygiene and willing patients who can attend study visits.
- Symmetrical number of permanent teeth in each arch (mesial to second molars).
Who cannot join
- Active carious lesions.
- Labial surface restorations.
- Intrinsic and extrinsic stains.
- Patients who have a significant medical history or if they are smokers.
- Patients who participated in clinical study during the preceding six months of the start of this trial.
- Criteria for discontinuation; Mortality and acquiring severe debilitating disease.
About this study
Official title: Remineralization Potential of Bioactive Varnish Versus Sodium Fluoride Varnish in Management of White Spot Lesions: Randomized Controlled Trial
This randomized controlled trial is held to investigate the effectiveness of two remineralizing agents surface pre-reacted glass-ionomer (S-PRG) filler and fluoride in management of white spot lesions.
Read the detailed description
Surface pre-reacted glass-ionomer (S-PRG) technology represents a newer bioactive approach that extends beyond the effects of fluoride alone. S-PRG fillers release multiple ions, including fluoride, strontium, sodium, silicate, borate, and aluminum, which act synergistically to promote remineralization, buffer acidic conditions, and inhibit bacterial activity In vitro and clinical evidence indicates that S-PRG-containing materials promote enamel remineralization and lesion stabilization, as laboratory studies have shown enhanced subsurface lesion repair, reduced lesion depth, and improved enamel surface morphology compared with controls, while clinical applications of PRG Barrier Coat have demonstrated significant reductions in white spot lesion area and increased enamel hardness for up to one year
- Conditions
- White Spot Lesion
- Being tested
- S-PRG barrier coat, Profluorid Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-PRG barrier coatOther
varnish containing Surface pre-reacted glass-ionomer technology
Profluorid VarnishOther
Fluoride varnish
| Study group | Role | What they receive |
|---|---|---|
| S-PRG barrier coat | Experimental | varnish containing Surface pre-reacted glass-ionomer technology Receives: Other: S-PRG barrier coat |
| Profluorid Varnish | Active comparator | Fluoride varnish Receives: Other: Profluorid Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients tooth caries lesion state
FDI Criteria (Visual examination of active caries lesion)
Measured: 6 months
Secondary outcomes (1)
Patients' tooth color change
VITA Easy Shade (ΔE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazin Mohamed Ibrahim, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602660
- Sponsor's protocol ID
- 5-2026
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Potential of Bioactive Varnish Versus Sodium Fluoride Varnish in Management of White Spot Lesions: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07602660
- Acronym / sponsor ID
- 5-2026
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2026 (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.
This randomized controlled trial is held to investigate the effectiveness of two remineralizing agents surface pre-reacted glass-ionomer (S-PRG) filler and fluoride in management of white spot lesions.
Detailed description
Surface pre-reacted glass-ionomer (S-PRG) technology represents a newer bioactive approach that extends beyond the effects of fluoride alone. S-PRG fillers release multiple ions, including fluoride, strontium, sodium, silicate, borate, and aluminum, which act synergistically to promote remineralization, buffer acidic conditions, and inhibit bacterial activity In vitro and clinical evidence indicates that S-PRG-containing materials promote enamel remineralization and lesion stabilization, as laboratory studies have shown enhanced subsurface lesion repair, reduced lesion depth, and improved enamel surface morphology compared with controls, while clinical applications of PRG Barrier Coat have demonstrated significant reductions in white spot lesion area and increased enamel hardness for up to one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-PRG barrier coat | Experimental | Other: S-PRG barrier coatvarnish containing Surface pre-reacted glass-ionomer technology |
| Profluorid Varnish | Active comparator | Other: Profluorid VarnishFluoride varnish |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients within 16-35 years of age.
- Each patient has 4 or more WSLs
- Mild and moderate WSLs.
- Good oral hygiene and willing patients who can attend study visits.
- Symmetrical number of permanent teeth in each arch (mesial to second molars).
Key exclusion criteria (6 listed)
- Active carious lesions.
- Labial surface restorations.
- Intrinsic and extrinsic stains.
- Patients who have a significant medical history or if they are smokers.
- Patients who participated in clinical study during the preceding six months of the start of this trial.
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 |
|---|---|---|
| S-PRG barrier coatvarnish containing Surface pre-reacted glass-ionomer technology | Other | S-PRG barrier coat |
| Profluorid VarnishFluoride varnish | Other | Profluorid Varnish |
Primary outcome
Patients tooth caries lesion state
Time frame: 6 months
FDI Criteria (Visual examination of active caries lesion)
1 secondary outcome
Patients' tooth color change
Time frame: 6 months
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 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing S-PRG barrier coat and Profluorid Varnish in people with White Spot Lesion, run by Future University in Egypt.
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 5 inclusion and 6 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 22 May 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients tooth caries lesion state (time frame: 6 months). 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 22 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.