Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

20. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

110

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Saudská arábie
    • Al-Qassim Region
      • Buraidah, Al-Qassim Region, Saudská arábie, 52571
        • Qassim University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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.
Aktivní komparátor: 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.
Jiný: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Weighted Peer Assessment Rating (PAR) Index
Časové okno: 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.
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Parental Satisfaction
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Murad Alrashidi

Vyšetřovatelé

  • Vrchní vyšetřovatel: MURAD A ALRASHDI, Qassim University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

1. května 2027

Dokončení studie (Odhadovaný)

1. května 2027

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

20. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 26-20-2

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení 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 podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Palatal Expansion Technika

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Philippines

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit