An interventional study of S-PRG barrier coat in Root Caries, sponsored by Cairo University. Status unknown. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 58 is close to the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Silver diamine fluoride (SDF) contains high concentrations of silver and fluoride ions, which prevents and arrests root caries, as well as dentin caries in the primary teeth of young children. Unlike other fluoride products that mainly reduce the formation of new carious lesions, 38% SDF is an effective agent that can efficiently arrest the carious process, remineralize the decayed dental tissues, and protect the tooth structure against the for-mation of new caries lesions. The use of SDF can result in more caries-resistant tooth structures.
Other: S-PRG barrier coat
PRG barrier coat is a Giomer varnish from Shofu. It is a light cured Surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix. It has an immediate and long lasting effect. The (S-PRG) favors the re-lease of fluoride ions and its recharging that aid in remineraliza-tion and protection of the tooth structure in a way similar to the glass ionomer. The fluoride ions aid in the neutralization of the acidity of the oral cavity and decrease the plaque accumulation
Other: S-PRG barrier coat
S-PRG filler was the best composition of compressive strength and F- and B release acid buffering capacity. It was found to be the most promising for use as a novel cement.
Evaluation of caries arrest
Evaluation of caries arrest by visual tactile evaluation. (mean number of arrested carious lesions that become hard, smooth and free from plaque post application of both SDF and S-PRG varnishes).
Time frame: one year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2022; primary completion for Nov 2023, 13 months later.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 13 months is below that.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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