Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-11
SponsorMurad Alrashidi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Monitoring via Smartphone Application
Other interventionUse of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely.
Conventional Monitoring
Other interventionParticipants 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
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Teleorthodontics Group (TG)Experimental treatment 1 intervention
Group B: Conventional Group (CG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Murad Alrashidi
Lead sponsor
Qassim University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: