Remineralization Potential of Different Remineralizing Agents on Initial Enamel Caries: Laboratory Evaluations and Two-year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ICDAS II scores
研究概览
简要总结
To evaluate and compare the clinical effect of four different remineralizing agents on initial enamel caries after a two years follow up.
详细描述
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel-arm design.A young- age patients , who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Facultyof Dentistry, University of Mansoura. The study will focus on initial enamel caries on buccal or labial surfaces of permenant teeth.rior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from September 2024 to September 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.Sample size calculation was based on mean NYVAD scores between studied groups retrieved from previous research that most similar to our research using G power program version 3.1.9.7 to calculate sample size based on expected difference of 31% ,using 2-tailed test , α error =0.05 and power = 80.0% , the total calculated sample size will be at least 30 in each group with each patient having at least one active lesion.
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
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator) Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants should have at least one visible initial enamel caries in the permanent teeth
- •Only lesions with ICDAS II score of 1 or 2 could be included
- •The patients must have good oral hygiene
排除标准
- •patients receiving tetracyclines, any other medication known to stain teeth - Patients had fluoride application less than 3 months before the study
- •Teeth which have microcavities or dentinal involvement due to loss of enamel - Teeth that have discoloration, enamel hypoplasia or fluorosis.
研究组 & 干预措施
SAP fluoride plus
Participants in this group received P11-4 (Curodont Repair™, Biomedical products for tooth preservation) only at baseline. First, the tooth was completely isolated using rubber dam followed by cleaning of the tooth surface with sodium hypochlorite 2% for 20 s, acid etching with phosphoric acid gel 35-37% for 20 s, rinsing and drying.
干预措施: SAP fluoride plus (Procedure)
10% n-HAp
A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied
干预措施: 10% n-HAp. (Procedure)
10% n-BAG.
A Low-speed handpiece was used to clean the tooth surface with fluoride-free pumice (Pumice powder extra fine, SSWhite, Rio de Janeiro, Brazil) after tooth isolation, rinsing, and drying. after that the material was applied
干预措施: 10% n-BAG. (Procedure)
Flour Protector S
The teeth were dried and a very thin coat of the varnish was applied and allowed to dry for 20 s.
干预措施: Flour Protector S (Procedure)
结局指标
主要结局
ICDAS II scores
时间窗: assessment will be done at baseline and after 3, 6, 12 and 24 months.
Remineralization will be assessed using visual tactile assessment of white spot lesions based on change in ICDAS II scores (reduction from score 2 to 1, or from score 1 to 0).
次要结局
- DIAGNOdent score(assessment will be done at baseline and after 3, 6, 12 and 24 months.)