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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Palatal Expansion Technique; Orthodontics, Interceptive; Teledentistry
• Intervention / Treatment: Other: Remote Monitoring via Smartphone Application; Other: Conventional Monitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MURAD A ALRASHIDI, BDS; Phone Number: +966 55 302 2773; Email: MU.ALRASHIDI@qu.edu.sa

Study Locations

• Saudi Arabia
  • Al-Qassim Region
    • Buraidah, Al-Qassim Region, Saudi Arabia, 52571
      • Qassim University
      • Contact: MURAD ALRASHIDI, BDS, MSC; Phone Number: +966 55 302 2773; Email: MU.ALRASHIDI@qu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children aged 7 to 11 years
2. Scheduled to commence interceptive orthodontic treatment with a maxillary or mandibular Hyrax® expansion appliance
3. In the mixed dentition stage
4. 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
5. Parent or guardian able and willing to provide written informed consent, and child able to provide assent

Exclusion Criteria:

1. Craniofacial syndromes or congenital craniofacial anomalies
2. Requirement for complex multidisciplinary management
3. Lack of reliable internet access, defined as inability to upload photographs at least once per week
4. Any prior orthodontic treatment
5. Significant systemic medical conditions affecting orthodontic treatment outcomes
6. Absence of a consistent legal guardian available to participate in the monitoring protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teleorthodontics Group (TG); Participants receive Phase I expansion therapy with a Hyrax® expander. Monitoring includes weekly remote intraoral photography via the Dental Monitoring platform and scheduled in-office visits every 8 weeks.	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.
Active Comparator: Conventional Group (CG); Participants receive the same Phase I expansion therapy with a Hyrax® expander. Monitoring follows a standard protocol with in-office visits scheduled every 4 weeks.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weighted Peer Assessment Rating (PAR) Index	This measure assesses the clinical effectiveness of the orthodontic treatment by calculating the difference between the baseline PAR score and the score at the completion of Phase I therapy. A single blinded and calibrated examiner performs the measurements using study models or digital scans. The trial is designed as a non-inferiority test, with a pre-specified margin of -3 points.	12 months
Number of Unscheduled Emergency In-Person Visits.	This measure tracks healthcare utilization and service efficiency by counting the total number of emergency or unscheduled clinic visits required for each participant. These visits are triggered by patient-reported concerns or, in the remote monitoring group, by clinical issues detected during AI-assisted photo review. This outcome is tested for superiority conditional on establishing the non-inferiority of the PAR Index change.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Satisfaction	Parental satisfaction with the assigned monitoring modality will be assessed at the treatment midpoint and at treatment completion using the Modified Telehealth Satisfaction Questionnaire (MTSQ). The MTSQ comprises 16 items distributed across four domains: convenience (4 items), communication (4 items), clinical confidence (4 items), and overall experience (4 items). Each item is rated on a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). Total scores are calculated as the sum of all items and range from a minimum of 16 to a maximum of 80, with higher scores indicating greater parental satisfaction with the monitoring experience.	12 months
Child-Reported Experience	The child's level of pain or distress associated with the monitoring process will be assessed using the Wong-Baker FACES Pain Rating Scale, a self-report instrument validated for children aged 3 years and older. The scale presents six cartoon faces ranging from a smiling face to a crying face, each corresponding to a numeric value: 0 (no hurt), 2 (hurts little bit), 4 (hurts little more), 6 (hurts even more), 8 (hurts whole lot), and 10 (hurts worst). Scores therefore range from a minimum of 0 to a maximum of 10, with higher scores indicating greater pain or distress.	12 months
Adverse Events and Safety	he frequency and severity of any adverse events, such as mucosal irritation, loose bands or brackets, and appliance deformation, will be monitored throughout the trial	12 months

Collaborators and Investigators

• Sponsor: Murad Alrashidi
• Investigators: Principal Investigator: MURAD A ALRASHDI, Qassim University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Phase I Orthodontic Treatment; Interceptive Orthodontics; Hyrax Appliance; Teleorthodontics
• Other Study ID Numbers: 26-20-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will share individual participant data that underlie the results reported in the final publication, after de-identification. This may include the weighted PAR Index scores, number of unscheduled visits, and survey responses (MTSQ and Wong-Baker FACES scales).The study protocol and statistical analysis plan (SAP) will be made available upon request. Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No