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

NCT07611227 | Not Yet Recruiting DMC

• 1 other identifier: 26-20-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Teledentistry; Orthodontics, Interceptive; Palatal Expansion Technique

Keywords

Phase I Orthodontic Treatment; Interceptive Orthodontics; Hyrax Appliance; Teleorthodontics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Parental Satisfaction

  12 months

• Child-Reported Experience

  12 months

• Adverse Events and Safety

  12 months

Study Arms (2)

Teleorthodontics Group (TG)

EXPERIMENTAL

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

Conventional Group (CG)

ACTIVE COMPARATOR

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

Interventions

Remote Monitoring via Smartphone Application OTHER

Use of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely.

Teleorthodontics Group (TG)

Conventional Monitoring OTHER

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

Conventional Group (CG)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Murad Alrashidi: lead

Study Sites (1)

Qassim University

Buraidah, Al-Qassim Region, 52571, Saudi Arabia

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• MURAD A ALRASHDI

  Qassim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MURAD A ALRASHIDI, BDS

CONTACT

+966 55 302 2773; MU.ALRASHIDI@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor In Orthodontics and Pediatric Dentistry

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• 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.

Locations

SA (1)