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临床试验/NCT03990935
NCT03990935Unknown不适用

Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions: "A Randomized Controlled Trial"

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
(white spot lesion progression)

研究概览

简要总结

To evaluate the effectiveness of ginger and rosemary herbals versus sodium fluoride in remineralization of incipient enamel caries.

详细描述

Group 1 (intervention)

Ginger and rosemary gel application:

First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

Group 2 (control group). Sodium fluoride varnish The fluoride varnish will be bifluorid 10 single use by voco (Germany). It Contains 5 % sodium fluoride (equal to 22,600 ppm fluoride).

A thin coat will be applied on the tooth surface by using a brush. 10-20 s are sufficient for the varnish to be absorbed and then dry with air. Participants will be informed that they should not brush their teeth for 12-24 hours after the application and not to eat, or drink for at least 30 minutes after use to get the best results.

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

  • Patient who has just completed a comprehensive orthodontic treatment.
  • Presence of at least one WSL, DIAGNOdent score (0-20).
  • Age range between 13 and 35years.

排除标准

  • Patients with a compromised medical history.
  • Severe or active periodontal disease
  • Patients with developmental hypo-calcified lesions

研究组 & 干预措施

sodium fluoride varnish

Active Comparator

The fluoride varnish will be bifluorid 10 single use by voco (Germany). It Contains 5 % sodium fluoride (equal to 22,600 ppm fluoride).

A thin coat will be applied on the tooth surface by using a brush. 10-20 s are sufficient for the varnish to be absorbed and then dry with air. Participants will be informed that they should not brush their teeth for 12-24 hours after the application and not to eat, or drink for at least 30 minutes after use to get the best results.

干预措施: ginger and rosemary gel (Other)

Ginger and rosemary gel

Experimental

First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

干预措施: ginger and rosemary gel (Other)

结局指标

主要结局

(white spot lesion progression)

时间窗: T0 Baseline T1 1 months T2 3 months T3 6 months

The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).

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

Nada Hamada Ahmed Shehab Eldin

resident at operative dentistry department,cairo university

Cairo University

研究点 (1)

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