Efficacy of Self-assembling Peptide P11-4, Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in lesion fluorescence evaluated using diode laser fluorescence device.
研究概览
简要总结
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.
详细描述
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. These lesions are characterized by white chalky appearance. As caries is reversible under favorable conditions, many approaches have focused on treating it as soon as possible1.
Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients. This will be achieved using visual assessments and laser fluorescence investigation.
The proposed study is a randomized controlled clinical trial with split-mouth design. Included are forty positive patients aged 9-17 years, with at least four visible WSL on smooth surfaces in permanent teeth, requiring non-operative treatment. WSL will be assessed visually by ICDAS II, Nyvad criteria and laser fluorescence (LF pen). The lesions are randomly assigned into 4 groups (n = 40): Gr NT (no treatment, control group), Gr CR (Curodont Repair), Gr V (MI Varnish), Gr I (Icon) groups. Lesions will be assessed by International Caries Detection and Assessment System, Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1, 3, 6 and 12 months.
Data will be analyzed with intention-to-treat concept by Student T-test for paired samples, Wilcoxon signed rank test, P< .05. Pre-test on 20 subjects resulted in n=41 patients sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This is a double-blinded trial, i.e., where patients and outcomes assessor are not aware which white spot lesion what treatment will receive, unlike the operator which is not blinded for the study due to the nature of the investigated techniques.
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the study are children 9 to 17 years old.
- •Obtained written informed consent from parents or gave-givers as well as obtained verbal informed consent from the child to participate in the study, in which procedures are explained in age-appropriate manner.
- •Children, identified as positive or definitely positive through Frankl behavioral rating scale.
- •Presence of at least four initial carious lesions of smooth surface (white spots) in permanent teeth that reach the inside of the enamel but are not cavitated, estimated with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change), Nyvad caries activity criteria (1 -active, noncavited lesion) and DIAGNOdent pen values up to
- •Study participants did not conduct remineralizing or topical fluorine therapy of the lesions involved up to six months prior to inclusion in the study.
- •Children without a history of allergy to the administered medications
排除标准
- •Patients with general diseases or conditions associated with decreased salivation and intake of medications suppressing salivary current. Children with cognitive and behavioral disorders. The presence of a disease is confirmed by an anamnestic interview with the parent.
- •Children with a history of allergy to the administered medications
- •Patient with non-carious lesion such as enamel hypoplasia, or any developmental defects.
- •Patient received restorations or any remineralizing agent other than the regular toothpaste during the last 6 months.
- •Participant in another trial.
研究组 & 干预措施
SAP11-4 group (Gr CR)
The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions.
干预措施: Self-assembling peptide (P11-4) (Drug)
CPP-ACFP group (Gr V)
The Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions.
干预措施: CPP-ACFP (Drug)
Resin infiltration group (Gr I)
The Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions.
干预措施: Resin infiltration (Drug)
Control group (Gr NT)
The control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.
干预措施: Control Group, No Treatment (Other)
结局指标
主要结局
Change in lesion fluorescence evaluated using diode laser fluorescence device.
时间窗: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Laser fluorescence values are categorized: 20-24 * Category 0= LF values 0-7, caries-free enamel surface * Category 1=LF values 8-14, caries extending up to halfway through the enamel * Category 2=LF values 15-24, caries in the inner half of enamel * Category 3= LF values \>24, caries in dentine
次要结局
- Visual assessment using ICDAS II coding system(12 months: (Baseline, 1 month, 3 months, 6months and 12 months))
- Activity of a carious lesion using Nyvad Caries Diagnostic Criteria(12 months: (Baseline, 1 month, 3 months, 6months and 12 months))