White Spot Lesion of ToothNCT07126366
Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions
A study testing S-PRG Barrier coat and S-PRG Prophylaxis paste in people with White Spot Lesion of Tooth, run by Cairo University.
Trial summary
The aim of the study is to evaluate and compare the long-term color stability of two bioactive materials used in the management of white spot lesions: Surface Pre-Reacted Glass (S-PRG) containing resin-based light-cured varnish and S-PRG containing prophylaxis paste. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- S-PRG Barrier coat and S-PRG Prophylaxis paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2025to 21 Oct 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient consulting in the outpatient clinic.
- Enamel caries in anterior permanent teeth according to ICDAS-1 and ICDAS-2.
- Good oral hygiene.
- Provide informed consent.
- Cooperative and willing to participate in the trial.
- Male or female.
- Adult patients aged 16 to 35 years.
Who cannot join
- Spontaneous or elicited pain from caries.
- Tooth mobility.
- Signs of pulpal infection.
- Severe medical conditions that would not allow management in the clinic.
- Hereditary developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta.
- Known allergies or sensitivities to dental materials, including fluoride
Show all 9Show fewer
- Inability to return for recall visits.
- Poor oral hygiene.
- Refusal to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
engy hassan aref abdelaziz engy aref, bachelor degree (BDS) contact
About this study
Official title: COLOR STABILITY OF S-PRG RESIN-BASED LIGHT CURE VARNISH AND PROPHYLAXIS PASTE ON WHITE SPOT LESIONS: A 12-MONTH RANDOMIZED CLINICAL TRIAL
The aim of the study is to evaluate and compare the long-term color stability of two bioactive materials used in the management of white spot lesions: Surface Pre-Reacted Glass (S-PRG) containing resin-based light-cured varnish and S-PRG containing prophylaxis paste. The study will assess color changes over a 12-month period to determine which material better maintains aesthetic integrity while providing therapeutic benefits for demineralized enamel surfaces.
Read the detailed description
White spot lesions (WSLs), particularly prevalent in post-orthodontic patients (up to 96%), pose both aesthetic and pathological challenges due to subsurface enamel demineralization that alters optical properties. Although fluoride-based remineralization therapies can arrest lesion progression, they often fail to restore the natural appearance of enamel, leaving residual opacity.
Surface Pre-Reacted Glass (S-PRG) technology offers a bioactive alternative, releasing multiple therapeutic ions (e.g., fluoride, strontium, silicate) to enhance remineralization, neutralize acids, and exhibit antibacterial effects. S-PRG materials are available in resin-based varnishes and prophylaxis pastes; however, their long-term color stability remains underexplored.
Given that aesthetic outcomes significantly impact patient satisfaction, this study aims to compare the 12-month color stability of S-PRG resin-based varnish versus S-PRG prophylaxis paste. Color changes may result from water sorption, dietary staining, polymer degradation, and ion interaction with oral fluids. The comparison is clinically relevant as both materials utilize the same bioactive core but differ in formulation and application methods.
A 12-month observation period allows assessment under real oral conditions, including pH fluctuations and staining challenges. Objective color evaluation using CIE Lab* values and spectrophotometry ensures standardized, clinically relevant data. The study targets anterior teeth due to their aesthetic significance and addresses a critical gap in the literature, supporting evidence-based selection of materials that balance therapeutic efficacy with long-term aesthetic outcomes in WSL management.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- S-PRG Barrier coat, S-PRG Prophylaxis paste
- Keywords
- S-PRG, White spot lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-PRG Barrier coatOther
A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening.
S-PRG Prophylaxis pasteOther
S-PRG Prophylaxis paste is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction.
| Study group | Role | What they receive |
|---|---|---|
| S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan | Active comparator | A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening. Receives: Other: S-PRG Barrier coat |
| S-PRG PROPHYLAXIS PASTE | Experimental | S-PRG PROPHYLAXIS PASTE is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction. Receives: Other: S-PRG Prophylaxis paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months
Primary Outcome Measure 1:
Title: Visual Caries Assessment Using ICDAS Criteria Description: Visual/tactile examination of white spot lesions according to the International Caries Detection and Assessment System (ICDAS).
Score 0: No visible caries (sound tooth)
Score 1: First visual change in enamel (white or brown opacity, visible only when dry)
Score 2: Distinct visual change in enamel (opacity visible wet and dry)
Score 3: Localized enamel breakdown (no visible dentin)
Score 4: Underlying dark shadow from dentin (no cavitation)
Score 5: Distinct cavity with visible dentin
Score 6: Extensive cavity with visible dentin Time Frame: Baseline, 3 months, 6 months, 12 months Unit of Measure: ICDAS score (ordinal scale: 0-6)
Measured: at baseline, 3 months, 6 months and 12 months
Secondary outcomes (2)
Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.
Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.
Clinical success rate (ΔE ≤ 3.7)
Measured: at baseline, 3 months,6 months and 12 months
Patient satisfaction scores (VAS 0-10) Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months Clinical success rate (ΔE ≤ 3.7)
Patient satisfaction scores (VAS 0-10) Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months Clinical success rate (ΔE ≤ 3.7) -
Measured: at baseline, 3 months,6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start21 Sep 2025 (estimated)
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Oct 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 Lesion of ToothStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy hassan aref abdelaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126366
- Sponsor's protocol ID
- 14422023489475
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 17 Aug 2025
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLOR STABILITY OF S-PRG RESIN-BASED LIGHT CURE VARNISH AND PROPHYLAXIS PASTE ON WHITE SPOT LESIONS: A 12-MONTH RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07126366
- Acronym / sponsor ID
- 14422023489475
- Conditions
- White Spot Lesion of Tooth
- Keywords
- S-PRG, White spot lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2025 (estimated)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 17 Aug 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 aim of the study is to evaluate and compare the long-term color stability of two bioactive materials used in the management of white spot lesions: Surface Pre-Reacted Glass (S-PRG) containing resin-based light-cured varnish and S-PRG containing prophylaxis paste. The study will assess color changes over a 12-month period to determine which material better maintains aesthetic integrity while providing therapeutic benefits for demineralized enamel surfaces.
Detailed description
White spot lesions (WSLs), particularly prevalent in post-orthodontic patients (up to 96%), pose both aesthetic and pathological challenges due to subsurface enamel demineralization that alters optical properties. Although fluoride-based remineralization therapies can arrest lesion progression, they often fail to restore the natural appearance of enamel, leaving residual opacity.
Surface Pre-Reacted Glass (S-PRG) technology offers a bioactive alternative, releasing multiple therapeutic ions (e.g., fluoride, strontium, silicate) to enhance remineralization, neutralize acids, and exhibit antibacterial effects. S-PRG materials are available in resin-based varnishes and prophylaxis pastes; however, their long-term color stability remains underexplored.
Given that aesthetic outcomes significantly impact patient satisfaction, this study aims to compare the 12-month color stability of S-PRG resin-based varnish versus S-PRG prophylaxis paste. Color changes may result from water sorption, dietary staining, polymer degradation, and ion interaction with oral fluids. The comparison is clinically relevant as both materials utilize the same bioactive core but differ in formulation and application methods.
A 12-month observation period allows assessment under real oral conditions, including pH fluctuations and staining challenges. Objective color evaluation using CIE Lab* values and spectrophotometry ensures standardized, clinically relevant data. The study targets anterior teeth due to their aesthetic significance and addresses a critical gap in the literature, supporting evidence-based selection of materials that balance therapeutic efficacy with long-term aesthetic outcomes in WSL management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan | Active comparator | Other: S-PRG Barrier coatA light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening. |
| S-PRG PROPHYLAXIS PASTE | Experimental | Other: S-PRG Prophylaxis pasteS-PRG PROPHYLAXIS PASTE is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patient consulting in the outpatient clinic.
- Enamel caries in anterior permanent teeth according to ICDAS-1 and ICDAS-2.
- Good oral hygiene.
- Provide informed consent.
- Cooperative and willing to participate in the trial.
Key exclusion criteria (9 listed)
- Spontaneous or elicited pain from caries.
- Tooth mobility.
- Signs of pulpal infection.
- Severe medical conditions that would not allow management in the clinic.
- Hereditary developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta.
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 coatA light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession or temporary sensitivity due to whitening. | Other | S-PRG-Barrier coat ,Shofu Inc. Kyoto, Japan |
| S-PRG Prophylaxis pasteS-PRG Prophylaxis paste is a bioactive Giomer-based paste containing S-PRG particles that release six therapeutic ions-fluoride, strontium, borate, aluminum, sodium, and silicate each contributing to remineralization, antibacterial effects, and dentin sensitivity reduction. | Other | S-PRG PROPHYLAXIS PASTE |
Primary outcome
Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months
Time frame: at baseline, 3 months, 6 months and 12 months
Primary Outcome Measure 1: Title: Visual Caries Assessment Using ICDAS Criteria Description: Visual/tactile examination of white spot lesions according to the International Caries Detection and Assessment System (ICDAS). Score 0: No visible caries (sound tooth) Score 1: First visual change in enamel (white or brown opacity, visible only when dry) Score 2: Distinct visual change in enamel (opacity visible wet and dry) Score 3: Localized enamel breakdown (no visible dentin) Score 4: Underlying dark shadow from dentin (no cavitation) Score 5: Distinct cavity with visible dentin Score 6: Extensive cavity with visible dentin Time Frame: Baseline, 3 months, 6 months, 12 months Unit of Measure: ICDAS score (ordinal scale: 0-6)
2 secondary outcomes
Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months.
Time frame: at baseline, 3 months,6 months and 12 months
Patient satisfaction scores (VAS 0-10) Color stability measured by spectrophotometric analysis (ΔE values) at baseline, 3, 6, and 12 months Clinical success rate (ΔE ≤ 3.7)
Time frame: at baseline, 3 months,6 months and 12 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 17 Aug 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.
engy hassan aref abdelaziz engy aref, bachelor degree (BDS) contact
Questions about this trial
What is this clinical trial studying?
A study testing S-PRG Barrier coat and S-PRG Prophylaxis paste in people with White Spot Lesion of Tooth, 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 7 inclusion and 9 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 17 Aug 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.
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 engy hassan aref abdelaziz engy aref, bachelor degree (BDS) (01126538662, engy.aref@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months (time frame: at baseline, 3 months, 6 months and 12 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 17 Aug 2025.