Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children

Official title

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.

Overview

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: 1. Is remote monitoring non-inferior to conventional care in improving dental alignment, as measured by the Peer Assessment Rating (PAR) Index? 2. Does the use of weekly smartphone-based photo check-ins significantly lower the number of unscheduled emergency visits? 3. 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: 1. Commence Phase I treatment using a maxillary or mandibular expansion appliance. 2. If assigned to the teleorthodontics group, capture a standardized set of five intraoral photographs weekly via a dedicated smartphone application. 3. Attend scheduled in-office checkups every 4 or 8 weeks, depending on their assigned group. 4. Maintain a daily diary to record appliance activations and report on their treatment experience.

Detailed description

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.

Technical Monitoring and Safety In the teleorthodontics group, the AI system will flag clinical concerns such as loose bands or activation errors. The trial will investigate if these automated alerts allow for the remote resolution of minor issues, thereby preventing unnecessary travel for the families. Safety will be monitored by recording all adverse events, including mucosal irritation or appliance deformation, in both groups.

Statistical Methodology The trial is powered to detect non-inferiority based on a pre-specified margin of -3 points on the weighted PAR Index. Primary Analysis: An Intention-to-Treat (ITT) approach will be used, employing ANCOVA adjusted for baseline PAR scores and age strata. Emergency Visits: Superiority regarding unscheduled visits will be analyzed using negative binomial regression, accounting for treatment duration and travel distance. Sensitivity Analyses: To ensure robustness, researchers will perform per-protocol (PP) analyses and multiple imputation by chained equations (MICE) to handle any missing data. Subgroup Analysis: Exploratory analyses will examine if treatment effects differ based on the severity of the initial malocclusion or the geographic distance the family must travel to the clinic.

Interventions

• Other Remote Monitoring via Smartphone Application
  Use of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely.
• Other Conventional Monitoring
  Participants follow a standard care protocol involving physical examinations during in-person clinic visits scheduled every 4 weeks. No digital monitoring or smartphone-based photography is utilized

Primary outcome measures

• Change in Weighted Peer Assessment Rating (PAR) Index [Time frame: 12 months]
• Number of Unscheduled Emergency In-Person Visits. [Time frame: 12 months]

Secondary outcome measures (3)

• Parental Satisfaction [Time frame: 12 months]
• Child-Reported Experience [Time frame: 12 months]
• Adverse Events and Safety [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Saudi Arabia · 1 center

• Qassim University — Buraidah

Publications

• Kazimierczak N, Kazimierczak W, Serafin Z, Nowicki P, Nozewski J, Janiszewska-Olszowska J. AI in Orthodontics: Revolutionizing Diagnostics and Treatment Planning-A Comprehensive Review. J Clin Med. 2024 Jan 7;13(2):344. doi: 10.3390/jcm13020344. PMID 38256478
• Kengne Talla P, Allison P, Bussieres A, Rodrigues A, Bergeron F, Giraudeau N, Emami E. Teledentistry for Improving Access To, and Quality of Oral Health Care: Overview of Systematic Reviews and Meta-Analyses. J Med Internet Res. 2025 Jul 30;27:e65211. doi: 10.2196/65211. PMID 40737673
• DeGuzman L, Bahiraei D, Vig KW, Vig PS, Weyant RJ, O'Brien K. The validation of the Peer Assessment Rating index for malocclusion severity and treatment difficulty. Am J Orthod Dentofacial Orthop. 1995 Feb;107(2):172-6. doi: 10.1016/s0889-5406(95)70133-8. PMID 7847276

Identifiers

NCT: NCT07611227 · 26-20-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗