A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
This is three-arm Randomized Controlled Trial. The main goal is to evaluate the effectiveness of self-assembling peptide P11-4 (SAP P11-4) in the remineralization of enamel carious white spot lesions. Participants with carious white spot lesions will be assigned to one of three study groups and remineralisation agents will be applied according to the study protocol. The primary objective is to assess changes in the carious white spot lesions over time using quantitative light-induced fluorescence and clinical evaluation.
详细描述
This study will be conducted at an academic center. Recruitment will include patients aged 10 to 18 years presenting with carious white spot lesions on the smooth surfaces of permanent teeth at the Department of Pediatric Dentistry, Medical University of Warsaw. The planned study duration is 1 year. After assessment of the inclusion and exclusion criteria and enrollment into the study, participants will undergo randomization and will be allocated to 1 of 3 study groups.
Group A will receive a single application of Curodont Repair (self-assembling peptide P11-4) at the first visit, together with fluoride varnish application every 3 months (Duraphat Fluoride Varnish, Colgate, 22,600 ppm fluoride). Group B will receive repeated applications of Curodont Repair at the first visit, after 3 months, together with fluoride varnish application every 3 months. Group C, the control group, will receive only fluoride varnish every 3 months.
There is currently limited evidence regarding the effectiveness of repeated applications of remineralization agents containing self-assembling peptide P11-4. In addition, this study includes a relatively long follow-up period, allowing evaluation of the durability of the treatment effect over time.
At each follow-up visit, scheduled every 3 months, white spot lesions will be assessed using quantitative light-induced fluorescence (QLF) and visual clinical examination.
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
- Single (Outcomes Assessor)
盲法说明
The study will be blinded at the pre-randomization stage. Until randomization, the participant and investigators will not know the intended group allocation.After randomization the trial becomes partially blinded for two investigators, who will be aware of the assigned group and will be responsible for delivering the intervention, visual-tactile examination and documenting adverse events. The third investigator will remain blinded throughout the study and will not have access to information on the participant's allocation. Only this investigator will be responsible for QLF assessments.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >10 years and <18 years.
- •Presence of at least 2 active enamel carious white spot lesions on a smooth tooth surface (labial/buccal surfaces of permanent teeth) based on International Caries Detection (ICDAS II) and Assessment System -Lesion Activity Assessment (ICDAS-LAA), and Lesion Activity Assessment (LAA criteria).
- •Tooth eligible for treatment:
- •Vital pulp,
- •no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA>7;
- •QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),
- •no history of trauma to the tooth.
- •Systemically healthy patient.
- •No contraindications to the use of fluoride preparations.
- •No fixed orthodontic appliance.
- •Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.
排除标准
- •Systemic diseases or chronic medication use due to chronic conditions.
- •Viral/bacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction).
- •Pregnancy or breastfeeding.
- •Allergy to any component of the SAP P11-4 preparation or the fluoride varnish.
- •Professional fluoride prophylaxis performed <3 months ago.
- •Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA<7, LAA code 0, 2-
- •Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin).
- •Developmental enamel defects.
- •Patient undergoing orthodontic treatment with fixed appliances.
- •Inability to ensure regular follow-up visits.
- •Lack of cooperation from the guardian or the patient.
- •Refusal to participate in the study and/or absence of written consent.
研究者
Dorota Olczak-Kowalczyk
Proffesor
Medical University of Warsaw