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

20 maja 2026 zaktualizowane przez: Murad Alrashidi

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

110

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Arabia Saudyjska
    • Al-Qassim Region
      • Buraidah, Al-Qassim Region, Arabia Saudyjska, 52571
        • Qassim University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Aktywny komparator: 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.
Inny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Weighted Peer Assessment Rating (PAR) Index
Ramy czasowe: 12 months
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.
Ramy czasowe: 12 months
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Parental Satisfaction
Ramy czasowe: 12 months
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
Ramy czasowe: 12 months
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
Ramy czasowe: 12 months
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Murad Alrashidi

Śledczy

  • Główny śledczy: MURAD A ALRASHDI, Qassim University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

12 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 26-20-2

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

Data will be available beginning 6 months and ending 36 months following article publication.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Technika rozszerzania podniebienia

Badania kliniczne na Remote Monitoring via Smartphone Application

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