Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the size of the white spot lesions using photographic assessment
研究概览
简要总结
In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a 9-months follow up using a high resolution Nikon camera with Canon 700D body. Canon EF 100mm f2.8 USM Macro Lens and Nissin MF18 ring flash Canon fit for better illumination. Also, A set of retractors and A set child occlusal mirrors with A contraster for assessment of the remineralization progress of the white spot lesion.
详细描述
A total of sixty (60) patients with early white spot lesions will be randomly selected to share in this study from the out-patient clinic of pedodontics and orthodontic department, Faculty of dentistry, Ain Shams University.
An informed consent will be signed by the patients and parents before their enrollment in the current study in which the aim of the study, the methodology and possible complications will be clearly described. This research will be reviewed by the research ethics committee, Faculty of dentistry, Ain Shams University. This In-vivo study will aim to evaluate the effectiveness of the SPR-G filler material sealants when compared to the fluoride varnish and the MI paste.
Precise medical, dental and family history will be taken from all patients through a direct interview and diagnostic sheet.
Teeth will be polished using a polishing brush and paste, and dried thoroughly before being examined.
Clinical examination will be done using a dental mirror and aided by the tactile detection of a dental explorer under LED illumination to make sure that the patients fulfill the inclusion criteria, followed by radiographic examination. All examination and follow up procedures will be done by the same operator to ensure standardization.
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, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 10-16 years old
- •Patient is healthy and medically free.
- •Moderate to high level of patient cooperation
- •Compliance of the primary caregiver
- •Moderate to high caries risk
- •Completed or in transitional fixed orthodontic treatment
- •At least 1 wsl should be present
排除标准
- •Poor oral hygiene
- •Deeply Cavitated white spot lesions
- •Medically Compromised patients.
- •Extremely Uncooperative patient or primary caregiver
- •Generalized white spot lesions in the mouth
研究组 & 干预措施
group of 20 participants receiving fluoride varnish
*Group (I): patients will receive Fluoride varnish ttt.
干预措施: Fluoride varnish (Drug)
group of 20 participants receiving PR-G Barrier coat
*Group (II): patients will receive PR-G Barrier coat
干预措施: PRG Barrier Coat (Drug)
group of 20 participants receiving MI Paste (CPP-ACP)
*Group (III): Patients will receive MI Paste (CPP-ACP)
干预措施: MI paste (Drug)
结局指标
主要结局
Change in the size of the white spot lesions using photographic assessment
时间窗: 9 months
participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months
次要结局
- Remineralization of the enamel surface(9 months)
研究者
Mariam Alsagheer
Master's Candidate
Ain Shams University