Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries
Condition: Proximal Caries
Study type: Interventional

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.
    

Intervention name(s): Curodont™ Repair; MI Varnish™; Profluorid® Varnish
Intervention type(s): Device; Device; Device
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): CURODONT™ REPAIR, Credentis AG, Windisch, Switzerland; MI Varnish™, GC America Inc., Alsip, IL, USA; VOCO Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled, three-arm parallel, double-blinded, split-mouth clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proximal caries, P11-4, CPP-ACFP, fluoride varnish