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临床试验/NCT03440996
NCT03440996已完成不适用

Comparison of Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste, Clinpro™ Tooth Crème, and MI-Paste Plus for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年1月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Photographic records and clinical examination

研究概览

简要总结

The purpose of the study is to determine if Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste Plus has an effect on the formation and resolution of white spot lesions for patients undergoing orthodontic treatment. This study will include 90 patients in the UAB Orthodontic Clinic.

详细描述

During the course of orthodontic treatment, the practitioner normally faces two common iatrogenic treatment side effects: root resorption and enamel decalcification, with the latter occurring at a much higher frequency. While the processes that lead to enamel demineralization are understood, methods to diminish or perhaps eliminate degradation of enamel surfaces are being searched for. Several approaches have been formulated to counteract demineralization of tooth structure. One approach involves patient compliance and consists of in-depth oral hygiene instructions, in-office fluoride applications, and at-home fluoride rinses, gels, and varnishes. An alternative approach, which possesses potential benefit regardless of patient compliance, includes the use of fluoride-releasing agents, such as composites, glass ionomers, sealants, and elastomeric ties.

Enamel decalcification or white spot formation, is a phenomenon occurring primarily on smooth enamel surfaces of teeth, notably within the gingival third of the crown. Demineralized enamel, the precursor to caries formation, can be attributed to fixed orthodontic appliances, and prolonged exposure to bacterial plaque. Bacterial plaque promotes the accumulation of acidic byproducts and demineralization that leads to successive changes in the optical properties of subsurface demineralized enamel. Progression to clinically detectable white spot lesions may occur as early as one month following the placement of orthodontic appliances.

Two new anti-cavity toothpastes, Clinpro™ 5000 with 1.1% Sodium Fluoride and Clinpro™ Tooth Crème with 0.21% Sodium Fluoride, are currently available and have been shown in some initial case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals and helps you produce saliva. Both the Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. They are available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.

Thus, this study will compare Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste, Clinpro™ Tooth Crème, and MI-Paste Plus for the prevention and reduction of white spot lesions during orthodontic treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Permanent dentition
  • •Patients that in the opinion of the investigator will be compliant with the use of the paste
  • •Patients who have not used extensive fluoride regimes
  • •12 years and older
  • •Subjects must use a non-fluoridated toothpaste (such as Tom's of Maine) for a one-week period prior to starting this trial.

排除标准

  • •Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study.
  • •Patient is currently using any investigational drug.
  • •Patient plans to relocate or move within six months of enrollment.
  • •Patients who have or are currently undergoing fluoride treatment for white spot lesions.
  • •Patients with IgE Casein Allergy

研究组 & 干预措施

Clinpro™ 5000

Experimental

Participants will use Clinpro™ 5000 to brush their teeth for two minutes twice daily for 4 months.

干预措施: Clinpro™ 5000 (Other)

Clinpro™ Tooth Crème

Experimental

Participants will use Clinpro™ Tooth Crème to brush their teeth for two minutes twice daily for 4 months.

干预措施: Clinpro™ Tooth Crème (Other)

MI-Paste Plus

Active Comparator

Participants will use MI-Paste Plus to brush their teeth for two minutes twice daily for 4 months.

干预措施: MI-Paste Plus (Other)

结局指标

主要结局

Photographic records and clinical examination

时间窗: Subjects will be reviewed every 4 weeks. Photographs will be taken for 4 times at monthly intervals. Changes will be compared and assessed. The duration of the observation is an average of 4 months.

Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.

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

Chung How Kau

Professor and Chairman

University of Alabama at Birmingham

研究点 (1)

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