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临床试验/NCT03330535
NCT03330535Unknown不适用

The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals

Riyadh Colleges of Dentistry and Pharmacy2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年5月1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
88
试验地点
2
主要终点
Change in Plaque Index

研究概览

简要总结

The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.

详细描述

Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants were having orthodontic fixed appliance treatment.
  • Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
  • Participants were willing to comply with given oral hygiene instructions.

排除标准

  • 未提供

研究组 & 干预措施

Verbal oral hygiene instructions

Active Comparator

Participants will receive verbal oral hygiene instructions during routine orthodontic visits.

干预措施: Verbal oral hygiene instructions (Behavioral)

Reminders once a week

Experimental

Participants will receive active reminders once a week.

干预措施: Reminders once a week (Behavioral)

Reminders three times a week

Experimental

Participants will receive active reminders three times a week.

干预措施: Reminders three times a week (Behavioral)

Daily reminders

Experimental

Participants will receive active reminders daily.

干预措施: Daily reminders (Behavioral)

结局指标

主要结局

Change in Plaque Index

时间窗: At baseline, 4 weeks and 8 weeks

Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.

Change in gingival index

时间窗: At baseline, 4 weeks and 8 weeks

Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration 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

Lecturer in Orthodontics and Clinic Director

Riyadh Colleges of Dentistry and Pharmacy

研究点 (2)

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