Evaluation of Self Assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions; Split Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in white spot lesion color using standardized cross-polarized photography and digital color analysis
研究概览
简要总结
This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. These white spots may persist for years and affect the esthetic appearance of teeth.
The study will include male and female patients aged 15 to 25 who have at least one early carious lesion (ICDAS scores 1 or 2) on each side of their upper or lower front teeth. The purpose is to determine which treatment - Self-Assembling Peptides (SAP P11-4, Curodont Repair™) or Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP, MI Varnish™) - is more effective in improving the color and reducing the size of these lesions.
Researchers will use a split-mouth design, where each patient receives both treatments - one on each side of the mouth. Standardized digital photographs will be taken before and after treatment to assess color changes and lesion size. Patients will also rate their satisfaction with the appearance of their teeth after treatment.
The main questions the study will answer are:
Does SAP P11-4 improve the color of white spot lesions more effectively than CPP-ACP?
Is there a noticeable difference in lesion size reduction between the two treatments?
How satisfied are patients with the outcomes of each treatment?
Participants will be followed up at 3, 6, and 9 months after treatment. The results aim to guide clinicians toward the most effective treatment to improve the appearance of white spot lesions in young patients after orthodontic care.
详细描述
White spot lesions (WSLs) are early signs of tooth decay that appear as milky white spots on tooth enamel, especially common after wearing braces. These lesions can last for many years and negatively affect appearance, especially on front teeth. This study investigates two promising treatment options to reverse or reduce the appearance of WSLs.
Study Design This is a randomized, split-mouth, double-blinded clinical trial conducted at the Operative Dentistry Department, Faculty of Dentistry, Ain Shams University. The trial includes patients between the ages of 15 and 25 with visible white spot lesions on both sides of their front teeth (ICDAS scores 1-2).
Each patient will receive:
SAP P11-4 (Curodont Repair) on one side of the mouth.
CPP-ACP (MI Varnish) on the other side.
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
The study is described as double-blinded, meaning:
Participants do not know which treatment is applied to which side.
Outcome Assessors (those evaluating lesion color/size from photographs and ICDAS scores) are also blinded to group assignment.
the Principal Investigator are not blinded, as they apply the interventions and know the treatment allocation during the procedure.
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
- 否
入选标准
- •Age between 15 and 25 years
- •Presence of at least one tooth on each side of the anterior region (from right canine to left canine) affected by early carious lesions (ICDAS II code 1 or 2)
- •Lesion size and form must be fully visible and accessible
- •Willing and able to attend all study visits and follow instructions
- •Good general health and oral hygiene
- •Not taking any medication that affects salivary flow
- •Provided written informed consent
排除标准
- •Evidence of tooth erosion
- •Prior fluoride varnish application before study treatment
- •Hypoplastic enamel defects or multiple restorations on facial surfaces of anterior teeth
- •High caries risk patients
- •Known or suspected allergy to milk proteins
- •Use of medications affecting salivary flow
研究组 & 干预措施
Arm 2 Title: CPP-ACP Treatment
. Arm 2 (CPP-ACP Treatment) - Description: Participants receive Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) (MI Varnish™) applied to white spot lesions on the opposite side of the anterior teeth. The varnish is applied at baseline and again after 3 or 6 months, according to manufacturer guidelines.
干预措施: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension (Other)
Arm 1 Title: SAP P11-4 Treatment
Participants receive Self-Assembling Peptides (SAP P11-4), a biomimetic agent that penetrates enamel white spot lesions and promotes remineralization by forming a 3D peptide scaffold within the lesion. The material is applied to white spot lesions on one side of the anterior teeth at baseline and again after 3 months, following manufacturer instructions.
干预措施: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension (Other)
结局指标
主要结局
Change in white spot lesion color using standardized cross-polarized photography and digital color analysis
时间窗: Baseline, 3 months, 6 months, and 9 months
The primary outcome is the change in the color of enamel white spot lesions, assessed through standardized digital photographs taken at baseline and at 3, 6, and 9 months. Images will be analyzed using eLAB-prime software for objective color quantification.
次要结局
- Change in lesion size of white spot lesions based on standardized clinical photographs(Baseline, 3 months, 6 months, and 9 months)