NCT04776785

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

Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish). The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.

Detailed description

First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly, test 1 lesions received P11-4+NaF combination, test 2 lesions received CPP-ACP+NaF varnish, and control lesions received NaF varnish alone. At the 6th and 12th months after the clinical applications, Profluorid® Varnish application was repeated for test 1 and control lesions, and MI Varnish™ application was repeated for test 2 lesions. At the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (DSR) methods.

Conditions

• Proximal Caries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-12-06
• Completion: 2021-01-08
• First posted: 2021-03-02
• Last updated: 2021-03-12

Locations

2 sites across 1 country: Turkey (Türkiye)