Teleorthodontics Versus Conventional Follow-up in Pediatric Patients During Phase I Interceptive Orthodontic Treatment. A Randomized Controlled Trial Protocol Comparing Clinical Effectiveness and Parental Satisfaction.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if teleorthodontic remote monitoring is as effective as traditional in-office care for children undergoing Phase I expansion therapy. It will also evaluate whether this technology can safely reduce the frequency of unscheduled emergency appointments.
Main Questions
The study aims to answer the following:
- Is remote monitoring non-inferior to conventional care in improving dental alignment, as measured by the Peer Assessment Rating (PAR) Index?
- Does the use of weekly smartphone-based photo check-ins significantly lower the number of unscheduled emergency visits?
- How does remote monitoring impact appliance compliance, parental satisfaction, and the child's level of distress during treatment?
Comparison
Researchers will compare a teleorthodontics group-which uses weekly smartphone photography and clinic visits every 8 weeks-to a conventional group receiving standard in-person follow-ups every 4 weeks.
Participant Activities
Participants will:
- Commence Phase I treatment using a maxillary or mandibular expansion appliance.
- If assigned to the teleorthodontics group, capture a standardized set of five intraoral photographs weekly via a dedicated smartphone application.
- Attend scheduled in-office checkups every 4 or 8 weeks, depending on their assigned group.
- Maintain a daily diary to record appliance activations and report on their treatment experience.
详细描述
This trial will evaluate the clinical and logistical impact of integrating artificial intelligence (AI)-driven remote monitoring into pediatric interceptive orthodontics. While teleorthodontics has shown success in adult populations, this study will focus on children aged 7-11 years, where craniofacial growth is rapid and treatment depends heavily on parental involvement.
Trial Design:
This prospective, two-arm, parallel-group, randomized non-inferiority trial will be conducted at a university-based orthodontic clinic. The study will follow a hierarchical testing structure: first establishing the non-inferiority of treatment effectiveness (PAR Index change), followed by testing the superiority of remote monitoring in reducing unscheduled emergency visits.
Intervention Protocols:
Participants will be randomized in a 1:1 ratio to one of two monitoring modalities: Teleorthodontics Group (TG):Participants will receive a maxillary or mandibular Hyrax® expansion appliance. Parents will be trained to use the DentalMonitoring® smartphone application to capture five standardized intraoral photographs every week. The platform will use AI-driven image analysis to detect changes in tooth position, appliance status, and oral hygiene. A calibrated orthodontist will review all submissions within 48 hours and communicate with parents via in-app messaging. Scheduled in-office visits will occur at 8-week intervals. Conventional Group (CG):Participants will receive the same expansion therapy but will follow a traditional 4-week in-office visit schedule. No remote monitoring technology or smartphone-based photography will be utilized in this group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data Analyst: The primary statistical analysis will be performed by an analyst who is blinded to the group allocation until after the analysis was locked and the report was signed.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7 to 11 years
- •Scheduled to commence interceptive orthodontic treatment with a maxillary or mandibular Hyrax® expansion appliance
- •In the mixed dentition stage
- •Parent or legal guardian owns and is able to operate a compatible smartphone (iOS 14 or higher, or Android 10 or higher) capable of running the Dental Monitoring application
- •Parent or guardian able and willing to provide written informed consent, and child able to provide assent
排除标准
- •Craniofacial syndromes or congenital craniofacial anomalies
- •Requirement for complex multidisciplinary management
- •Lack of reliable internet access, defined as inability to upload photographs at least once per week
- •Any prior orthodontic treatment
- •Significant systemic medical conditions affecting orthodontic treatment outcomes
- •Absence of a consistent legal guardian available to participate in the monitoring protocol
研究者
Murad Alrashidi
Assistant Professor In Orthodontics and Pediatric Dentistry
Qassim University