White Spot LesionsNCT07086235
Remineralization Capacity and Patient Satisfaction of Self-Assembling Peptide With Fluoride Versus Tooth Protective Coating With Surface Pre-Reacted Glass on White Spot Lesions
A study testing self-assembling peptide and S-PRG Barrier Coat in people with White Spot Lesions, run by Nahda University at 1 site in Egypt.
Trial summary
Cosmetics and esthetics are current trends of our society, as more and more patients are demanding for minimally invasive cosmetic enhancement without anesthesia, drilling and less expensive restorations. Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- self-assembling peptide and S-PRG Barrier Coat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2025to 16 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No systemic diseases. 2- He/ she has at least two teeth with white spot lesion due to orthodontic therapy.
- 3- Between the ages of 21 and 25 years of age.
Who cannot join
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3 mm or greater.
- Presencia de cavidades cariosas.
- Allergy to fluoride.
- Subjects who have evidence of reduced salivary flow or significant tooth wear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Split-Mouth Clinical Trial on Remineralization Capacity and Patient Satisfaction of Self-Assembling Peptide With Fluoride Versus Tooth Protective Coating With Surface Pre-Reacted Glass on White Spot Lesions
Cosmetics and esthetics are current trends of our society, as more and more patients are demanding for minimally invasive cosmetic enhancement without anesthesia, drilling and less expensive restorations. This technique may be considered as micro invasive treatment of smooth surface white spot lesions (WSL) and also one that allows for the recovery of natural tooth appearance. Dentists are frequently faced with the treatment of color aberrations of teeth, as WSL which is caused by demineralization of enamel, and labial white spots are frequently associated with fixed orthodontic treatment. Clinically, the appearance of the lesion is opaque white, due to the optical phenomenon caused by mineral loss and the difference in the refractive index of water and air that fill the spaces formed in the enamel. The milky color of WSL impairs dramatically the esthetic appearance thus reducing satisfaction of orthodontic therapy, making their treatment become nowadays mandatory. Regarding the diagnosis, it is essential that the dentist does not lose the ability to detect a carious lesion or a WSL through visual or photographic examination, as is the most conventional way. However, other forms of diagnosis have emerged, such as fluorescence devices, as well as microradiography and microcomputed tomography to facilitate and accelerate the diagnostic process.
Conventionally, topical fluoride application has been used to manage WSLs in which the structure of the tooth is altered due to fluorapatite, thus becoming more resistant to caries. However, this approach has the disadvantage of depending on patient compliance and its results can be disappointing when solely used in high-risk patients. A recent biomimetic material has been introduced to dental market, namely, Curodont Repair Fluoride Plus, which is regarded as a possible substitute to fluoride to arrest WSL progression with the aim of filling the intercrystalline spaces for enamel subsurface lesions through a self-assembling peptide that builds a supramolecular three-dimensional, fibrous network in the acidic environment attracts calcium phosphate from saliva and produced de novo hydroxyapatite crystals surrounding the matrix with containing fluoride which have synergistic effect and enhance faster remineralization in management of WSLs. Another recent generation of patented bioactive smart remineralizing material, S-PRG Barrier Coat has been launched to remineralize WSLs where S-PRG pretreated fluoro-boro-aluminosilicate glass with polyacrylic acid and water to recharge and release fluoride. Additionally, releasing more types of ions this aid in biofilm suppression, decrease adhesion of bacteria, buffering capacity of acids, and enhances remineralization. The aim of this study is to compare the remineralization capacity and patient satisfaction of self-assembling peptide with fluoride versus tooth protective coating with surface pre-reacted glass on white spot lesions.
- Conditions
- White Spot Lesions
- Being tested
- self-assembling peptide, S-PRG Barrier Coat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-assembling peptideDrug
According to the instructions of the manufacturer, the lesion will be treated with etch solution (Super Etch, SDI Ltd, Bayswater, Victoria, Australia) for 30 seconds to open up the pores to the subsurface lesion and subsequently will be washed and dried. Curodont Repair Fluoride Plus brush will be rehydrated with 0.05 ml of sterile water and a single drop of the resulting solution will be immediately applied to the lesion surface. Moisture control will be ensured until the Curodont Repair Fluoride Plus solution will be no longer visible (approximately two minutes).
S-PRG Barrier CoatDrug
According to the instructions of the manufacturer, after mixing one drop of activator with base, a thin film coating will be applied to the WSL area then will be left undistributed for 3 seconds and finally will be light cured for 10 seconds using LED light-curing unit.
| Study group | Role | What they receive |
|---|---|---|
| Curodont Repair Fluoride Plus | Experimental | Not described Receives: Drug: self-assembling peptide |
| S-PRG Barrier Coat | Experimental | Not described Receives: Drug: S-PRG Barrier Coat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change assessment
Spectrophotometric color measurements will be performed using Vita Easy Shade (VITA Zahnfabrik, Germany). Only the lightness difference (ΔL*) value between baseline and after treatment will be recorded in this study.
Measured: Base-line (before treatment), immediately after treatment, 1-month, 3-month, and 6-months.
Secondary outcomes (1)
Depth of White Spot Lesions
The depth of all lesions from all subjects will be assessed using DIAGNOdent (KaVo, Germany), which relies on measuring the amount of fluorescence released by organic substances in dental tissues when stimulated by a 655 nm laser diode.
Measured: Base-line (before treatment), immediately after treatment, 1-month, 3-months, and 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start16 Feb 2025
- Primary completion16 Aug 2025
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Wagih Al-Saudi, Nahda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086235
- Sponsor's protocol ID
- 00A-2-25-4
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Split-Mouth Clinical Trial on Remineralization Capacity and Patient Satisfaction of Self-Assembling Peptide With Fluoride Versus Tooth Protective Coating With Surface Pre-Reacted Glass on White Spot Lesions
- ClinicalTrials.gov ID
- NCT07086235
- Acronym / sponsor ID
- 00A-2-25-4
- Conditions
- White Spot Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 16 Aug 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 25 Jul 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.
Cosmetics and esthetics are current trends of our society, as more and more patients are demanding for minimally invasive cosmetic enhancement without anesthesia, drilling and less expensive restorations. This technique may be considered as micro invasive treatment of smooth surface white spot lesions (WSL) and also one that allows for the recovery of natural tooth appearance. Dentists are frequently faced with the treatment of color aberrations of teeth, as WSL which is caused by demineralization of enamel, and labial white spots are frequently associated with fixed orthodontic treatment. Clinically, the appearance of the lesion is opaque white, due to the optical phenomenon caused by mineral loss and the difference in the refractive index of water and air that fill the spaces formed in the enamel. The milky color of WSL impairs dramatically the esthetic appearance thus reducing satisfaction of orthodontic therapy, making their treatment become nowadays mandatory. Regarding the diagnosis, it is essential that the dentist does not lose the ability to detect a carious lesion or a WSL through visual or photographic examination, as is the most conventional way. However, other forms of diagnosis have emerged, such as fluorescence devices, as well as microradiography and microcomputed tomography to facilitate and accelerate the diagnostic process.
Conventionally, topical fluoride application has been used to manage WSLs in which the structure of the tooth is altered due to fluorapatite, thus becoming more resistant to caries. However, this approach has the disadvantage of depending on patient compliance and its results can be disappointing when solely used in high-risk patients. A recent biomimetic material has been introduced to dental market, namely, Curodont Repair Fluoride Plus, which is regarded as a possible substitute to fluoride to arrest WSL progression with the aim of filling the intercrystalline spaces for enamel subsurface lesions through a self-assembling peptide that builds a supramolecular three-dimensional, fibrous network in the acidic environment attracts calcium phosphate from saliva and produced de novo hydroxyapatite crystals surrounding the matrix with containing fluoride which have synergistic effect and enhance faster remineralization in management of WSLs. Another recent generation of patented bioactive smart remineralizing material, S-PRG Barrier Coat has been launched to remineralize WSLs where S-PRG pretreated fluoro-boro-aluminosilicate glass with polyacrylic acid and water to recharge and release fluoride. Additionally, releasing more types of ions this aid in biofilm suppression, decrease adhesion of bacteria, buffering capacity of acids, and enhances remineralization. The aim of this study is to compare the remineralization capacity and patient satisfaction of self-assembling peptide with fluoride versus tooth protective coating with surface pre-reacted glass on white spot lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair Fluoride Plus | Experimental | Drug: self-assembling peptide |
| S-PRG Barrier Coat | Experimental | Drug: S-PRG Barrier Coat |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No systemic diseases. 2- He/ she has at least two teeth with white spot lesion due to orthodontic therapy.
- 3- Between the ages of 21 and 25 years of age.
Key exclusion criteria (6 listed)
- Presence of enamel hypoplasia or dental fluorosis.
- Presence of tetracycline pigmentation.
- Periodontal pocketing of 3 mm or greater.
- Presencia de cavidades cariosas.
- Allergy to fluoride.
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 |
|---|---|---|
| self-assembling peptideAccording to the instructions of the manufacturer, the lesion will be treated with etch solution (Super Etch, SDI Ltd, Bayswater, Victoria, Australia) for 30 seconds to open up the pores to the subsurface lesion and subsequently will be washed and dried. Curodont Repair Fluoride Plus brush will be rehydrated with 0.05 ml of sterile water and a single drop of the resulting solution will be immediately applied to the lesion surface. Moisture control will be ensured until the Curodont Repair Fluoride Plus solution will be no longer visible (approximately two minutes). | Drug | Curodont Repair Fluoride Plus |
| S-PRG Barrier CoatAccording to the instructions of the manufacturer, after mixing one drop of activator with base, a thin film coating will be applied to the WSL area then will be left undistributed for 3 seconds and finally will be light cured for 10 seconds using LED light-curing unit. | Drug | S-PRG Barrier Coat |
Primary outcome
Color change assessment
Time frame: Base-line (before treatment), immediately after treatment, 1-month, 3-month, and 6-months.
Spectrophotometric color measurements will be performed using Vita Easy Shade (VITA Zahnfabrik, Germany). Only the lightness difference (ΔL*) value between baseline and after treatment will be recorded in this study.
1 secondary outcome
Depth of White Spot Lesions
Time frame: Base-line (before treatment), immediately after treatment, 1-month, 3-months, and 6-months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-assembling peptide and S-PRG Barrier Coat in people with White Spot Lesions, run by Nahda University at 1 site 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 2 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: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Color change assessment (time frame: Base-line (before treatment), immediately after treatment, 1-month, 3-month, and 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 26 Nov 2025.