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临床试验/NCT03789812
NCT03789812Unknown不适用

Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances

Riyadh Colleges of Dentistry and Pharmacy2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Change in plaque index

研究概览

简要总结

The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance

详细描述

Subjects were randomized into four groups, the first group will receive manual tooth brush with super floss, the second group will receive electric tooth brush with super floss, the third group will receive manual tooth brush with water dental flosser and the fourth group will receive electric tooth brush with water flosser.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • participants with fixed orthodontic appliance.
  • participants age 14 years and above and didn't have mental of physical disabilities.
  • participants willing to comply with given oral hygiene instructions.

排除标准

  • patients with mental retardation.
  • patients with systematic diseases.

研究组 & 干预措施

Manual Toothbrush with Superfloss

Active Comparator

Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day.

干预措施: Manual toothbrush (Device)

Manual Toothbrush with Superfloss

Active Comparator

Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day.

干预措施: Superfloss (Device)

Electric Toothbrush with Superfloss

Experimental

Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day.

干预措施: Electric Toothbrush (Device)

Electric Toothbrush with Superfloss

Experimental

Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day.

干预措施: Superfloss (Device)

Manual Toothbrush with Water Flosser

Experimental

Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day.

干预措施: Manual toothbrush (Device)

Manual Toothbrush with Water Flosser

Experimental

Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day.

干预措施: Dental Water Jet (Device)

Electric Toothbrush with Water Flosser

Experimental

Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day.

干预措施: Electric Toothbrush (Device)

Electric Toothbrush with Water Flosser

Experimental

Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day.

干预措施: Dental Water Jet (Device)

结局指标

主要结局

Change in plaque index

时间窗: baseline, after 4 weeks and after 8 weeks

plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque

Change in gingival index

时间窗: baseline, after 4 weeks and after 8 weeks

gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding

次要结局

未报告次要终点

研究者

发起方
Riyadh Colleges of Dentistry and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Alkadhi

Assistant professor

Riyadh Colleges of Dentistry and Pharmacy

研究点 (2)

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