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临床试验/NCT05853276
NCT05853276已完成不适用

Effectiveness of Brush DJ App to Improve Oral Hygiene Compliance in Patients With Fixed Orthodontic Appliances - Randomised Controlled Study.

IMU University, Malaysia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Plaque index by Sillness and Loe

研究概览

简要总结

In this day and age, smartphones are occupying big portions of our lives. Expanding development of mobile applications focusing on delivering behavioral health intervention have intrigued us to know better about their efficacy.

Hence the present study was conducted to determine the effectiveness of the Brush DJ app on improving the oral hygiene compliance of patients wearing fixed orthodontic appliances by assessing their gingival status.

Null hypothesis: There was no difference in the gingival status and oral hygiene status of patients between verbal oral hygiene instructions and oral hygiene instructions using the Brush DJ app.

Research hypothesis: There was a difference in the gingival status and oral hygiene status of patients between verbal oral hygiene instructions and oral hygiene instructions using the Brush DJ app

详细描述

The participants are randomly distributed into two groups where Group I receive only standard oral hygiene instruction and Group II receive reminders via Brush DJ mobile application in addition to standard oral hygiene instructions. For the standard oral hygiene protocol received by participants of both groups, all of them are instructed to use soft-bristled toothbrushes, fluoridated toothpaste and interdental toothbrush or super floss. Proper oral hygiene education is provided to all the participants with the following 2-minute-long combined brushing technique.

For the evaluation of oral hygiene compliance of each orthodontic patient in each group, the gingival index according to Loë and Silness and Silness and Loe plaque index are measured at baseline (T0), 4th week (T1) and 8th week (T2). These indices are one of the standardized indicators of gingival health as it provides quantitative evaluation of the gingival status. GI and PI scores are measured by a single investigator who is calibrated. The reliability assessed by the intraclass correlation coefficient (ICC) suggested good agreement (0.85 & 0.88) for GI and PI respectively.

Data will be collected, cleaned, coded before doing the statistical analysis. The data will be checked for the range of Mean gingival index and Plaque index which should be within the range.

Sample size: The sample size was calculated to be 30 in each group, assuming a power of 80%, confidence interval of 95%, standard deviation (SD) of 0.5 and the aim of finding a 0.3 difference in the groups' means. All 60 volunteers were assessed for their eligibility before their participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • participants who have smartphones with Android version ≥ 4.0.3 or IOS version ≥ 9 operating systems
  • participants willing to comply with given oral hygiene instructions
  • participants without periodontal disease and /or dental caries at the study onset
  • participants who receive their orthodontic appliances within one year after onset of study.

排除标准

  • participants with any mental and physical disability or craniofacial disorders
  • participants with enamel or dentin dysplasia
  • participants taking medications which affects plaque accumulation such as antibiotics or antibacterial mouth rinses
  • Participants with periodontal disease or dental caries at the onset of study.

研究组 & 干预措施

Intervention group

Experimental

This group downloads and uses Brush DJ app. Reminders are sent through this app to brush their teeth and along with this oral hygiene instructions are also given.

干预措施: Brush DJ app (Behavioral)

Control group

No Intervention

This group receives standard oral hygiene instructions

结局指标

主要结局

Plaque index by Sillness and Loe

时间窗: 12 weeks

Reduction in the mean plaque index scores

Gingival index by Loe and Silness

时间窗: 12 weeks

Reduction in the mean gingival index scores

次要结局

未报告次要终点

研究者

发起方
IMU University, Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shilpa Gunjal

Dr

IMU University, Malaysia

研究点 (2)

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