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

NCT04776785 | Completed DMC

• 1 other identifier: 2019-TDU-DİŞF-0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Proximal Caries

Keywords

Proximal caries, P11-4, CPP-ACFP, fluoride varnish

Outcome Measures

Primary Outcomes (1)

• The assessment of lesion progression by digital subtraction radiography (DSR)

  The primary outcome of the study was assessment of lesion progression (change in the lesions' opacity) by DSR readings, at 12th month.

  12 months after the clinical applications

Secondary Outcomes (2)

• The assessment of lesion progression by pair-wise visual reading of radiographs

  12 months after the clinical applications

• The assessment of lesion progression by independent visual reading of radiographs

  12 months after the clinical applications

Study Arms (3)

Group 1

EXPERIMENTAL

In Group 1, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control). At the 6th and 12th months after the clinical applications, Profluorid® Varnish application will be repeated for test 1 and control lesions.

Device: Curodont™ Repair; Device: Profluorid® Varnish

Group 2

EXPERIMENTAL

In Group 2, one lesion will be received self-assembling peptide P11-4 solution (Curodont™ Repair, Credentis AG, Windisch, Switzerland) followed by 5% NaF varnish (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (test 1). The other lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2). At the 6th and 12th months after the clinical applications; Profluorid® Varnish application will be repeated for test 1 lesions, and MI Varnish™ application will be repeated for test 2 lesions.

Device: Curodont™ Repair; Device: MI Varnish™; Device: Profluorid® Varnish

Group 3

ACTIVE COMPARATOR

In Group 3, one lesion will be received CPP-ACP varnish containing 5% NaF (MI Varnish™, GC America Inc., Alsip, IL, USA) (test 2). The other lesion will be received 5% NaF varnish alone (Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany) (control). At the 6th and 12th months after the clinical applications; MI Varnish™ application will be repeated for test 2 lesions, and Profluorid® Varnish application will be repeated for control lesions.

Device: MI Varnish™; Device: Profluorid® Varnish

Interventions

Curodont™ Repair DEVICE

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.

Also known as: CURODONT™ REPAIR, Credentis AG, Windisch, Switzerland

Group 1; Group 2

MI Varnish™ DEVICE

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.

Also known as: MI Varnish™, GC America Inc., Alsip, IL, USA

Group 2; Group 3

Profluorid® Varnish DEVICE

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.

Also known as: VOCO Profluorid® Varnish, VOCO GmbH, Cuxhaven, Germany

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth,
• Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (E1), the inner half of the enamel (E2) or the outer third of the dentin (D1),
• Children who had not any systemic disease that prevents the application,
• Cooperative children who allowed to radiographic examinations and clinical applications.

You may not qualify if:

• There is caries/restoration on the different surface of the tooth to be treated,
• There is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated,
• Non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (D2) or the inner third of the dentin (D3),
• There is cavitation on the proximal surface of the tooth to be treated,
• Non-cooperative children who had not allow to radiographic examinations and clinical applications,
• Children and parents who denied the participation in the follow-up appointments.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (2)

Izmir Katip Celebi Uni.

Izmir, Turkey (Türkiye)

Location

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Study Officials

• Merve Akcay, assoc. prof.

  Izmir Katip Celebi Uni

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: randomized controlled, three-arm parallel, double-blinded, split-mouth clinical trial

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 2, 2021
• Study Start: October 1, 2019
• Primary Completion: December 6, 2020
• Study Completion: January 8, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

TU (2)