Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Esthetic Improvement of white spot lesion
研究概览
简要总结
Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions
详细描述
Patient/population:
Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.
Intervention:
I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish
Comparator Resin Infiltration
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (a range from 7-14 years of age was determined)
- •Good general health (absence of disease/no handicaps, to ensure oral care at home)
- •Preserved pulp vitality of the teeth.
- •Consolidated oral care daily.
- •Agreement by patient and parents (or guardians) to participate in the study
排除标准
- •Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
- •Teeth revealing any restorations were excluded from the current study.
- •Any previous or planned WSL treatment.
研究组 & 干预措施
Self-Assembling Peptide (P11-4)
self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS)
干预措施: P11-4, a self-assembling peptide (Drug)
Self-Assembling Peptide (P11-4) with fluoride varnish
CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355).
干预措施: P11-4, a self-assembling peptide with flouride (Drug)
Resin Infilteration
ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant
干预措施: resin infilteration (Drug)
结局指标
主要结局
Esthetic Improvement of white spot lesion
时间窗: 6 months
Outcome Measure: Photographic analysis Outcome measuring device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software Outcome measuring unit: Percentage change
Tooth remineralization
时间窗: 6 months
ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99
次要结局
- Patient Satisfaction(6 months)
研究者
Dina El Kharadly
Lecturer in Pediatric Dentistry Department
October 6 University