Remineralization Capacity and Patient Satisfaction of Self-Assembling Peptide With Fluoride Versus Tooth Protective Coating With Surface Pre-Reacted Glass on White Spot Lesions

Not Applicable

Active, not recruiting

• Conditions: White Spot Lesions
• Interventions: Drug: self-assembling peptide; Drug: S-PRG Barrier Coat

• Registration Number: NCT07086235
• Lead Sponsor: Nahda University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-16
• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Study First Posted: 2025-07-25
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-08-16
• Study Completion: 2025-08-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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.

Exclusion criteria:

1. Presence of enamel hypoplasia or dental fluorosis.
2. Presence of tetracycline pigmentation.
3. Periodontal pocketing of 3 mm or greater.
4. Presencia de cavidades cariosas.
5. Allergy to fluoride.
6. Subjects who have evidence of reduced salivary flow or significant tooth wear.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curodont Repair Fluoride Plus	self-assembling peptide	-
S-PRG Barrier Coat	S-PRG Barrier Coat	-

Primary Outcome Measures

Name	Time	Method
Color change assessment	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.

Secondary Outcome Measures

Name	Time	Method
Depth of White Spot Lesions	Base-line (before treatment), immediately after treatment, 1-month, 3-months, and 6-months.	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.

Trial Locations

Locations (1)

Nahda University; 🇪🇬 Banī Suwayf, Egypt