Viewing Study NCT05509920


Ignite Creation Date: 2025-12-25 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
Study NCT ID: NCT05509920
Status: UNKNOWN
Last Update Posted: 2022-08-22
First Post: 2022-08-19
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish
Sponsor: Cairo University
Organization:

Study Overview

Official Title: Assessment of Arresting Root Surface Caries After the Application of PRG Bioactive Varnish Versus SDF Varnish Over a Period of 1 Year Follow up
Status: UNKNOWN
Status Verified Date: 2022-08
Last Known Status: NOT_YET_RECRUITING
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: Guidelines proved that arresting and remineralization of the root surface caries is better than weakening the tooth structure and restoring it. Manufacturer claims that PRG Barrier Coat effectively treats dental hypersensitivity by providing immediate and long-lasting relief. Also has the effect of eliminating the activity and sur-vival of pathogenic bacteria and hardening the dentin tissue of the affected areas.
Detailed Description: A light-cured varnish with extended protection time of up to 6 months, PRG barrier coat incorporates proprietary GIOMER tech-nology, "Surface Pre-Reacted Glass" for high fluoride release and re-charge, continuous release of fluoride, strontium, boron, sodium, aluminum, and zinc, acid neutralization and anti-plaque benefits with excellent self-adhesive abilities. The new material could be an alter-native to SDF varnish in root caries arrest to overcome its unfavor-able color and taste.

Products containing S-PRG fillers have been developed in a wide variety of areas such as tooth surface coating materials, seal-ants, restoration resins and dentifrices. The use of these materials is also expected to have the effect of improving the properties of enamel. In this seminar, we will introduce a new caries prevention using S-PRG filler The eluted ions from the S-PRG filler containing materials exhibit various functions, such as prohibition of biofilm attachment, anti-demineralization, remineralization, modification of apatite crystal, and acid-buffering effect. Each ion was confirmed its function. Par-ticularly, Strontium, Borate and Fluoride ions were involved during calcium phosphate nucleation to form modified nano-hydroxyapatite. The acid buffering effect was shown with the borate ion. As the results of those effects of ions, the various materials with S-PRG technology were proven to con-tribute to increase the acid resistance and the caries prevention.

Study Oversight

Has Oversight DMC: None
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?: None
Is an FDA AA801 Violation?: