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临床试验/NCT04032184
NCT04032184Unknown不适用

Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control 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 exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. 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: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) 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

  • Age range 20-50 years
  • High caries risk patients defined according to cariogram caries risk assessment model
  • On non-cariogenic diet
  • High plaque index
  • Systematically healthy
  • No orthodontic or prosthodontic appliance

排除标准

  • Age range less than 20 or more than 50 years
  • Low or moderate caries risk patients according to cariogram
  • Patients with a compromised medical history
  • Cariogenic diet patient
  • 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

Fluoride toothpaste

Active Comparator

干预措施: Fluoride toothpaste (Other)

fluoride toothpaste and chlorhexidine mouthwash

Experimental

干预措施: fluoride toothpaste and chlorhexidine mouthwash (Other)

fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Experimental

干预措施: fluoride toothpaste, chlorhexidine mouthwash, MI varnish (Other)

结局指标

主要结局

Caries Risk Assessment

时间窗: an average 3 months

will be evaluated by cariogram

次要结局

  • DMF scores(an average of 12 months)

研究者

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

Howaida Fakhry Fouad

Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university 2012

Cairo University

研究点 (2)

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