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临床试验/NCT04032210
NCT04032210Unknown不适用

The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
caries risk assessment

研究概览

简要总结

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants will be exposed to regimen including dual zinc plus arginine based toothpaste (Colgate total), (A2) represents participants will be exposed to regimen including zinc based toothpaste (Crest complete) and (A3) represents control group where participants will be used fluoride based toothpaste (Signal). The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T3) . In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T3), third visit (after 6 months: T6) and final visit (after 12 months: T12) to obtain the required data

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
  • Subjects of mean age 20-50 years.
  • Patients with high caries risk assessment according to Cariogram.
  • Non cariogenic diet patient
  • High plaque index
  • Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.

排除标准

  • • Patients with a compromised medical history.
  • Cariogenic diet patient.
  • Participants with severe or active periodontal disease.
  • Participants with a history of allergy to any of the drugs or chemicals used in the study.
  • Patients on any antibiotics during the past month

研究组 & 干预措施

Regimen using dual Zinc plus Arginine based toothpaste

Experimental

干预措施: dual Zinc plus Arginine based toothpaste (Colgate total) (Other)

Regimen using Zinc based toothpaste (Crest complete)

Experimental

干预措施: Zinc based toothpaste (Crest complete) (Other)

Fluoride based toothpaste (Signal)

Active Comparator

干预措施: Fluoride based toothpaste (Signal) (Other)

结局指标

主要结局

caries risk assessment

时间窗: Three months

will be evaluated by cariogram

次要结局

  • DMF score(12 months)

研究者

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

Esraa Abdel Ghaffar Ahmed Ali

resident of conservative department of faculty of oral and dental medicine

Cairo University

研究点 (2)

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