Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The assessment of lesion progression by digital subtraction radiography (DSR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1
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.
干预措施: Curodont™ Repair (Device)
Group 1
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.
干预措施: Profluorid® Varnish (Device)
Group 2
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.
干预措施: Curodont™ Repair (Device)
Group 2
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.
干预措施: MI Varnish™ (Device)
Group 2
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.
干预措施: Profluorid® Varnish (Device)
Group 3
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.
干预措施: MI Varnish™ (Device)
Group 3
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.
干预措施: Profluorid® Varnish (Device)
结局指标
主要结局
The assessment of lesion progression by digital subtraction radiography (DSR)
时间窗: 12 months after the clinical applications
The primary outcome of the study was assessment of lesion progression (change in the lesions' opacity) by DSR readings, at 12th month.
次要结局
- The assessment of lesion progression by independent visual reading of radiographs(12 months after the clinical applications)
- The assessment of lesion progression by pair-wise visual reading of radiographs(12 months after the clinical applications)
研究者
Merve AKCAY
Assoc. Prof. Dr.
Izmir Katip Celebi University