"Clinical Evaluation of Self-Assembling Peptides Versus Tri-Calcium Phosphate Based Varnish in Treatment of White Spot Lesions; Split-Mouth Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in color of white spot lesions
研究概览
简要总结
Brief Summary:
This randomized controlled clinical trial will evaluate the effectiveness of two remineralizing agents in the treatment of white spot lesions (WSLs) in young adults. White spot lesions are early signs of enamel demineralization that commonly develop after orthodontic treatment. The study will compare a self-assembling peptide-based varnish (Curodont Repair, SAP P11-4) with a tri-calcium phosphate-based varnish (Clinpro White Varnish, 3M) using a split-mouth design.
A total of patients aged 15-25 years with at least one eligible WSL on each side of the anterior teeth will be enrolled. Each patient will receive Curodont Repair on one side and Clinpro White Varnish on the contralateral side. Treatments will be applied at baseline and repeated after 3 months. Lesions will be evaluated using standardized digital photography, ICDAS II scoring, lesion size measurements, and patient satisfaction questionnaires at baseline, 3, 6, and 9 months.
The primary outcome is the change in color of white spot lesions over 9 months. Secondary outcomes include changes in lesion size, ICDAS scores, and patient-reported satisfaction. The study is double-blinded (patients and outcome assessors) and conducted at the Faculty of Dentistry, Ain Shams University.
详细描述
White spot lesions (WSLs) represent the earliest clinically detectable stage of enamel caries and are a common consequence of fixed orthodontic treatment. These lesions are characterized by increased opacity of enamel due to subsurface demineralization. Conventional fluoride-based strategies can promote surface remineralization but often fail to achieve full penetration into the lesion body, limiting complete enamel repair.
Novel biomimetic approaches, such as self-assembling peptides (SAP P11-4), have been developed to address this limitation. SAP molecules can diffuse into the subsurface lesion and form a three-dimensional scaffold that attracts calcium and phosphate ions from saliva, facilitating de novo hydroxyapatite formation and deeper remineralization. In contrast, tri-calcium phosphate (TCP) varnishes provide bioavailable minerals in combination with fluoride to enhance surface remineralization.
Although both strategies show promising laboratory and clinical results, there is limited evidence directly comparing their clinical performance in patients with orthodontically induced WSLs. This study aims to fill that gap by using a split-mouth, randomized controlled design to compare the effectiveness of Curodont Repair (SAP P11-4) and Clinpro White Varnish (TCP) in young adult patients.
The study will focus on the extent of remineralization as assessed by digital imaging and color analysis, supplemented by changes in lesion size and ICDAS II scoring. Patient satisfaction will also be evaluated to capture subjective outcomes of esthetic improvement. Findings from this study are expected to contribute to evidence-based recommendations for minimally invasive management of WSLs.
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
- Double (Participant, Outcomes Assessor)
盲法说明
"This study uses a double-blind split-mouth design. Participants and outcome assessors are blinded to the intervention allocation. The treating clinician cannot be blinded due to product differences in application, but will not be involved in outcome evaluation. Data analysis will be performed with blinded group coding."
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- A minimum of one tooth affected by early carious lesions (ICDAS-II codes 1 or 2) in both sides of the mouth that do not require invasive treatment.
- •Age 15 years and ≤ 25 years
- •Size and form of the carious lesions must both be fully visible, and accessible
- •Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
- •Provide written informed consent before participation in the study as subjects were minors, informed consent will provided by the parent and/or legal guardian.
- •patients not on medication affecting their salivary flow and medically free (ASA class I).
排除标准
- •Evidence of tooth erosion.
- •any form of fluoride application before the study treatment.
- •patients with hypoplastic enamel defects, multiple restorations on the facial surfaces.
- •High caries risk patients
结局指标
主要结局
Change in color of white spot lesions
时间窗: Baseline, 3 months, 6 months, and 9 months
"Change in color and appearance of white spot lesions will be assessed using standardized digital intraoral photography and eLAB color analysis system. The color difference (ΔE) values will be calculated to quantify remineralization."
次要结局
- Change in lesion size(Baseline, 3 months, 6 months, and 9 months)