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临床试验/NCT04357093
NCT04357093已完成不适用

Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Remineralization of white spot lesions

研究概览

简要总结

This clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.

详细描述

Natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries.

Previously, herbs are used in dentistry for prevention and curative purpose of dental caries. The main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance.

Grape seed extract (GSE) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth.

Grape seed extract (GSE), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. There are multiple bioactive properties in GSE, but in particular, its rich content of proanthocyanidins (PACs) plays a role in its theoretical benefit in caries prevention.

PACs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 30 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
  • Age range between 13 and 30years.

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.
  • Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.

结局指标

主要结局

Remineralization of white spot lesions

时间窗: Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .

changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)

次要结局

  • Satisfaction of the patient: questionnaire(After 6 months)

研究者

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

Nada Abd El Sattar Mohamed Kotb

Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Cairo University

研究点 (1)

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