跳至主要内容
临床试验/NCT03656432
NCT03656432Unknown3 期

Effect of CPP-ACP Pastes With/Without Fluoride on White Spot Lesion Progression, Salivary pH and Fluoride Release in High Caries Risk Patients A Randomized Clinical Trial

Cairo University0 个研究点目标入组 42 人开始时间: 2018年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
42
主要终点
White Spot Lesion (WSL) progression

研究概览

简要总结

Effect of CPP-ACP pastes with/without Fluoride on White spot lesion progression, salivary pH and fluoride release in high caries risk Patients, over 3 month period using VistaCam, Digital pH meter and Selective ion electrode.

详细描述

Dental caries is the most prevalent disease affecting the Human beings, it is a complex disease affecting teeth, which is caused by imbalance between demineralization and remineralization process in the oral cavity.

Preventive measures will stop the development of early caries lesions or even will direct the progression of this early carious lesions towards remineralization.

Nowadays, researchers have focused on non-invasive techniques to prevent early caries lesions appearance. In recent years, a calcium and phosphate remineralization technology has been introduced to decrease their incidence that relies on Casein Phospho-Peptide-Amorphous Calcium Phosphate (CPP-ACP).

The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.

CPP-ACP with sodium fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite . It also has a preventive role in the pH control as it might be able to improve pH levels in different areas in the oral cavity.

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
17 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 17-30 years
  • Males or females
  • High caries risk patients defined according to American Dental Association (ADA)
  • Systematically healthy
  • Not taking any medication interfering with saliva secretion
  • Co-operative patients approving to participate in the trial
  • signed informed consent

排除标准

  • Patients younger than 17 years old or older than 30 years old.
  • Disabilities
  • Subjects suffering from any medical or systematic disease
  • Pregnant females
  • Allergy to milk derivatives.
  • using any other agents containing fluoride
  • presence of untreated caries lesions.

研究组 & 干预措施

CPP-ACP paste

Experimental

MI Paste represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.

干预措施: CPP-ACP paste (Drug)

CPP-ACP containing fluoride

Experimental

MI paste plus contains fluoride 0.2% (900 ppm) that is very similar to the amount of fluoride in the toothpaste binds to the tooth surfaces and plaque and provides biocompatible calcium, phosphate and fluoride in a localized way. So, it provides all the ions needed to build fluorapatite crystals that are more resistant to the acid attack compared to hydroxyapatite

干预措施: CPP-ACP paste (Drug)

toothpaste contains fluoride

Active Comparator

Fluoridated Toothpaste are the most significant and worldwide spread forms of caries control used globally as the greater acceptability of toothpaste makes its regular use more likely, thereby improving effectiveness

干预措施: CPP-ACP paste (Drug)

结局指标

主要结局

White Spot Lesion (WSL) progression

时间窗: (T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.

The researcher will inspect the development of any new WSLs in the oral cavity in the clinic of Conservative Dentistry Department Cairo University. The software quantifies the green and red fluorescent light on a scale from 0 to 3 as a ratio of red to green, showing the areas with a higher than healthy tooth ratio.

次要结局

  • unstimulated Salivary pH change((T1) baseline before application, (T2) immediate after application, (T3) 1 day, (T4) 1 week and (T5) 1 month.)
  • stimulated Fluoride Release(For the WSLs assessment, (T1) baseline before application, (T2) 1 month and (T3) 3 months)

研究者

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

Doaa Gamal

Principal Investigator and PHD student at Conservative Dentistry Department

Cairo University

相似试验

Effect of CPP-ACP With/Without Fl on White Spot... | 临床试验