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临床试验/NCT07835022
NCT07835022已完成不适用

Effectiveness of a Smartphone Application Versus Conventional Verbal Motivation on Oral Hygiene in Patients Undergoing Fixed Orthodontic Treatment: A Randomized Controlled Trial

Atlas University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月8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
50
试验地点
1
主要终点
Dental plaque percentage (computer-assisted planimetry)

研究概览

简要总结

This study looked at whether a smartphone app can help patients with fixed braces keep their teeth cleaner than usual spoken advice alone. Fixed braces make plaque harder to remove, which can harm the teeth and gums, so good brushing habits matter.

Fifty patients aged 14 to 22 were divided at random into two groups. One group used a purpose-made app ("iTeeth Orthodontics") that sent brushing reminders, timed brushing, and kept a brushing log. The other group received the usual spoken oral-hygiene motivation. Both groups used the same brushes, toothpaste, and rinse, and followed the same cleaning routine.

Plaque was measured from photographs at 10 days and at 1, 2, and 3 months, using a computer to calculate how much of each tooth surface was covered by plaque. The two groups were then compared.

详细描述

ackground and objective: Maintaining oral hygiene during fixed orthodontic treatment is difficult, and patient motivation is central to preventing plaque accumulation, enamel demineralization, and gingival inflammation. This trial compared a purpose-built smartphone application with conventional verbal motivation for plaque control during fixed orthodontic treatment.

Design: Prospective, randomized, controlled, parallel-group (1:1) in vivo trial conducted at the Department of Orthodontics, Faculty of Dentistry, Ondokuz Mayıs University (Samsun, Türkiye). Fifty patients (14-22 years) with Class I or II malocclusion who owned and used a smartphone were enrolled and allocated equally to a mobile group (app plus standard regimen) or a control group (verbal motivation plus the identical regimen).

Intervention: The "iTeeth Orthodontics" application provided treatment information, customizable brushing reminders (push notifications), an adjustable brushing timer with interdental-brush and mouthrinse prompts, and a daily/weekly/monthly brushing log. Both groups used identical brackets, archwires, toothbrushes, interdental brushes, toothpaste, and mouthrinse, and followed the same oral-hygiene regimen (modified Bass brushing three times daily, nightly interdental cleaning, and mouthrinse), so that the motivational method was the only variable.

Outcome and assessment: Plaque was recorded at day 10 (T0) and at 1 (T1), 2 (T2), and 3 (T3) months. After application of a disclosing agent, standardized intraoral photographs were taken, and the disclosed plaque area on the maxillary central incisors, canines, and second premolars was quantified by computer-assisted planimetry as a percentage of the total visible buccal crown surface. The outcome assessor was blinded to group and time point. Between-group and over-time comparisons were then performed.

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
Single (Outcomes Assessor)

盲法说明

ingle-blind (outcome assessor). Intraoral photographs were coded by the supervisor, and the examiner who performed the planimetric plaque measurements was unaware of group allocation and time point until all measurements were completed. Participants and care providers could not be blinded because of the nature of the intervention.

入排标准

年龄范围
14 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • * Aged 14-22 years
  • Accepted for fixed orthodontic treatment
  • Skeletal and/or dental Class I or Class II malocclusion
  • Owns and regularly uses a smartphone
  • Completed permanent dentition
  • No systemic disease and no continuous (long-term) medication

排除标准

  • * Skeletal malocclusion severe enough to require orthognathic (surgical) treatment
  • Motor, physical, or mental impairment interfering with toothbrushing
  • Congenitally missing or pre-treatment extracted teeth
  • Impacted or supernumerary teeth
  • Teeth with shape anomalies -

研究组 & 干预措施

Mobile group

Experimental

Participants used the purpose-built "iTeeth Orthodontics" smartphone application (treatment information, customizable brushing reminders/push notifications, an adjustable brushing timer with interdental-brush and mouthrinse prompts, and a daily/weekly/monthly brushing log), together with the standardized oral-hygiene regimen and materials used by both groups.

干预措施: Smartphone application for oral-hygiene motivation (iTeeth Orthodontics) (Behavioral)

Control group

Active Comparator

Participants received conventional verbal oral-hygiene motivation, without the smartphone application, together with the identical standardized oral-hygiene regimen and materials used by both groups.

干预措施: Conventional verbal oral-hygiene motivation (Behavioral)

结局指标

主要结局

Dental plaque percentage (computer-assisted planimetry)

时间窗: Day 10 (T0, baseline) and at 1 month (T1), 2 months (T2), and 3 months (T3)

Amount of dental plaque expressed as the disclosed plaque area as a percentage of the total visible buccal crown surface. After application of a plaque-disclosing agent, standardized intraoral photographs were taken and the plaque area on the maxillary central incisors, canines, and second premolars was quantified by computer-assisted planimetry. Lower values indicate less plaque (better oral hygiene). The outcome assessor was blinded to group and time point.

次要结局

  • Tooth-type-specific dental plaque percentage(Day 10 (T0) and at 1 month (T1), 2 months (T2), and 3 months (T3))

研究者

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

Selim Arici

Prof. Dr.

Ondokuz Mayıs University

研究点 (1)

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