跳至主要内容
临床试验/NCT03966378
NCT03966378Unknown不适用

Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients

Cairo University0 个研究点目标入组 24 人开始时间: 2019年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Quantitative changes of white spot lesions

研究概览

简要总结

Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.

详细描述

The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.

These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.

This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

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)

入排标准

年龄范围
13 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.

排除标准

  • Severe or active periodontal disease.
  • Patients had received therapeutic irradiation to the head and neck region.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for recall appointments
  • Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
  • Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.

研究组 & 干预措施

Grape seeds extract

Experimental

Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant.

干预措施: Grape seeds extract (Other)

Casein-phosphopeptide/amorphous-calcium phosphate

Active Comparator

CPP-ACP paste apply to the teeth twice daily.

干预措施: Casein-phosphopeptide/amorphous-calcium phosphate (Other)

结局指标

主要结局

Quantitative changes of white spot lesions

时间窗: evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .

changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aseel Saleh Omeran

pricipal investigator

Cairo University

相似试验