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临床试验/NCT03823612
NCT03823612Unknown4 期

Reminerlization Potential of Innovative Biomimetic Material Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Caries White Spot Lesions "A Randomized Clinical Trial"

Cairo University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
34
试验地点
1
主要终点
esthetic assessment

研究概览

简要总结

to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.

详细描述

Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.

The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.

Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.

Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients should have at least one white spot caries lesion
  • age from 18 to 40 years
  • no gender restriction

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

GC tooth mousse

Experimental

Drug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride)

干预措施: GC tooth mousse (Drug)

clinpro tooth creme

Active Comparator

it contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient

other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

干预措施: Clinpro Tooth Creme (Drug)

结局指标

主要结局

esthetic assessment

时间窗: baseline, after 1 month , 3 months and 6 months of the application

Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study

次要结局

  • patient compliance(6 months)

研究者

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

donia mahmoud abd el moaty; Doniamahmoud17@gmail.com

principle investigator in cairo university

Cairo University

研究点 (1)

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