Remineralization efficacy of CPP-ACP with Fluoride versus Sodium Fluoride mouthwash on white spot lesions among orthodontic patients- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Remineralization efficacy of CPP-ACP with Fluoride in terms of EDI and ICDAS scores
研究概览
简要总结
Anew product, GC Tooth Mousse Plus, is currently available and has been shown insome initial reports to be useful in the reduction of white spot lesions.Although GC Tooth Mousse Plus does not remove the need for compliance, it ishoped that it provides a new way to prevent and resolve decalcifications thatdevelop during orthodontic treatment. GC Tooth Mousse Plus reportedly restoresminerals to the teeth and helps to stimulate saliva production. This productcontains 900 p.p.m. fluoride with added calcium and phosphate, in a compositionideal for depositing fluorapatite into enamel. A crucial component of theproduct is the milk-derived protein casein phosphopeptide (CPP), whichstabilizes amorphous calcium phosphate (ACP). This is converted to fluorapatitedeposited in enamel by the available fluoride.11
Thereare few studies regarding the effect of calcium phosphate and hydroxyapatitebased agents on remineralization and optical appearance of WSLs followingorthodontic therapy. The results of a recent systematic review suggest thatthere is a tendency toward a benefit for the use of GC Tooth Mousse Plus overbrushing with a fluoride toothpastemouthrinse for regression of WSLs inorthodontic patients but the quality of evidence is limited. With thisbackground this study will be conducted to evaluate the remineralizationefficacy of CPP-ACP with fluoride (GC Tooth Mousse Plus) and Sodium Fluoride mouthrinseon white spot lesions during orthodontic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Orthodontic patients with fixed orthodontic appliances on the facial surface of the maxillary and mandibular incisors, and canines.
- •2.Subjects of 12 years age or above.
- •3.Subjects with atleast two active white spot lesions (Nyvad criteria) on the facial surface of the maxillary, mandibular incisors and canine at the time of recruitment of study subjects.
- •4.Subjects with verifiable records of bonding with non-sealing and non-fluoride releasing bonding agents/cements.
- •5.Subjects with at least 12 months of fixed appliance therapy remaining from the time of recruitment.
排除标准
- •1.Subjects with milk protein allergy, 2.Subjects with untreated cavitated lesions or extensive restorations on the facial surfaces of the study teeth, 3.Subjects with intrinsic or extremely heavy extrinsic staining on facial surface of the maxillary, mandibular incisors and canine.
- •4.Subjects with moderate to severe fluorosis, 5.Subjects with dental morphologic/ anatomical/developmental anomalies 6.Subjects with any medical illness/or on any medications for dental or systemic disease.
- •7.Planned to relocate or move within 6 months of enrolment.
结局指标
主要结局
Remineralization efficacy of CPP-ACP with Fluoride in terms of EDI and ICDAS scores
时间窗: Baseline, 1st week , 2nd week , 3rd week , 1 month , 2nd month and 3rd month
次要结局
- NA(NA)