Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

December 6, 2020

Study Completion Date

January 8, 2021

Conditions
Proximal Caries
Interventions
DEVICE

Curodont™ Repair

"It is a product used in biomimetic remineralization of initial carious lesions. The product consists of smart P11-4 peptide molecules (CUROLOX® TECHNOLOGY) that within the lesion the molecules self-assemble to a 3D matrix. This bio-matrix enables the regeneration of the tooth tissue.~Test 1 lesions will be cleaned with a prophylaxis paste and isolated with cotton rolls. Then, the pellicle will be removed using 2% sodium hypochlorite (20 sec) and the inorganic deposits will be removed using 35% phosphoric acid (20 sec). The tooth surface will be rinsed with water and dried. Thereafter, Curodont™ Repair will be applied in compliance with the manufacturers' instructions and left for 5 minutes."

DEVICE

MI Varnish™

"MI Varnish™ is a 5% sodium fluoride (NaF) varnish that has a desensitizing action when applied to tooth surfaces. The product also contains RECALDENT™ (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. The application leaves a film of varnish on tooth surfaces and also facilitates the tooth remineralization.~Test 2 lesions will be isolated with cotton rolls. Then, MI Varnish ™ will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area."

DEVICE

Profluorid® Varnish

"Profluorid® Varnish is a 5% sodium fluoride (NaF) varnish for surface application to enamel and dentin. The product will adhere to wet surfaces and is tolerant to moisture and saliva. Profluorid® Varnish is an ethanolic suspension of colophony with artificial flavors and sweetened with xylitol. It is also used in the remineralization of initial caries.~Control lesions will be isolated with cotton rolls. Then, Profluorid® Varnish will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area."

Trial Locations (2)

Unknown

Izmir Katip Celebi Uni., Izmir

Izmir Katip Celebi University, Izmir

All Listed Sponsors
lead

Izmir Katip Celebi University

OTHER

NCT04776785 - Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries | Biotech Hunter | Biotech Hunter