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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Nahda University

    Banī Suwayf

Other trials in Egypt

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.

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 groups in NCT07086235
Study groupRoleWhat they receive
Curodont Repair Fluoride PlusExperimentalNot described
Receives: Drug: self-assembling peptide
S-PRG Barrier CoatExperimentalNot described
Receives: Drug: S-PRG Barrier Coat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted25 Jul 2025
  2. Study start16 Feb 2025
  3. Primary completion16 Aug 2025
  4. Study completion16 Aug 2025

Resources

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)
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

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.

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