Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-30 @ 7:09 PM
Study NCT ID:
NCT07086235
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remineralization Capacity and Patient Satisfaction of Self-Assembling Peptide With Fluoride Versus Tooth Protective Coating With Surface Pre-Reacted Glass on White Spot Lesions
Sponsor:
Nahda University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: