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Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE

3 ottobre 2026 aggiornato da: Hasan KILINÇ, Adiyaman University

Evaluation of Three-Dimensional Facial Soft Tissue Changes and Their Clinical Perceptibility Following Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients.

A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation.

Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals.

Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes.

The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

his single-center prospective controlled observational study will investigate facial soft tissue changes associated with miniscrew-assisted rapid palatal expansion (MARPE) in postpubertal individuals.

Three-dimensional facial images will be obtained using the MetiSmile facial scanning system (Shining 3D, Hangzhou, China) under standardized conditions, including natural head position, neutral facial expression, and relaxed lips.

The MARPE group will be evaluated at three time points: before appliance activation (T0), following completion of active expansion (T1), and after a three-month retention period (T2). The control group will undergo facial scanning at baseline and at a follow-up interval corresponding to the T0-T2 observation period.

Regional soft tissue changes will be assessed in the nasal, alar base, paranasal, nasolabial, midfacial, and upper lip regions. Clinical perceptibility will be investigated through blinded orthodontic specialist assessments of standardized facial image pairs. Patient-reported perception of facial changes will also be recorded using structured questionnaires.

Where routine clinical CBCT records are available, skeletal expansion and intermolar width changes will be measured and their relationships with regional facial soft tissue changes will be investigated. No additional radiographic examinations will be performed solely for research purposes.

Comparisons between the MARPE and control groups will be used to distinguish expansion-associated facial changes from changes occurring during the observation period.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Adıyaman Province
      • Adıyaman, Adıyaman Province, Turchia (Türkiye), 02040
        • Adiyaman University Faculty of Dentistry, Department of Orthodontics
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 16 anni a 25 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population will consist of 60 postpubertal orthodontic patients aged 16-25 years recruited from the Department of Orthodontics, Faculty of Dentistry, Adiyaman University, Türkiye. The MARPE group will include 40 patients undergoing clinically indicated maxillary expansion, while the control group will consist of 20 age- and skeletal maturation-matched orthodontic patients who will not receive maxillary expansion during the observation period. All participants will be prospectively followed using three-dimensional facial scans. Treatment decisions will be made independently of study participation.

Descrizione

Inclusion Criteria:

  • Individuals aged 16-25 years.
  • Postpubertal skeletal maturation confirmed by cervical vertebral maturation (CVM) assessment using existing lateral cephalometric radiographs.
  • Patients with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE), determined independently of the study (MARPE group).
  • Orthodontic patients matched for age and skeletal maturation who will not undergo maxillary expansion during the observation period (control group).
  • Willingness to participate and provision of informed consent (and parental/legal guardian consent for participants under 18 years).

Exclusion Criteria:

  • History of previous maxillary expansion treatment.
  • Previous or planned orthognathic surgery during the observation period.
  • Facial aesthetic procedures or surgical interventions that may influence soft tissue morphology during follow-up.
  • Systemic diseases or craniofacial conditions affecting bone or soft tissue development.
  • Maxillary expansion performed in control participants during the observation period.
  • Inability to complete the required facial scans or follow-up assessments.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
MARPE Group

Participants aged 16-25 years with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE). A total of 40 participants will undergo routine MARPE treatment independently of the study. Three-dimensional facial scans will be obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2).
Dispositivo: Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes.
Control Group

Twenty age- and skeletal maturation-matched orthodontic patients who will not undergo maxillary expansion during the observation period. Routine orthodontic treatment may continue. Three-dimensional facial scans will be obtained at two time points corresponding to the baseline and three-month retention follow-up interval of the MARPE group.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Three-Dimensional Facial Soft Tissue Changes Following MARPE
Lasso di tempo: Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.

Three-dimensional facial soft tissue changes will be evaluated using MetiSmile facial scans. Regional changes in the nasal, paranasal, midfacial, zygomatic, and upper lip areas will be quantified in millimeters (mm) by comparing baseline and follow-up scans. Changes from T0 to T2 will be compared between the MARPE and control groups. Additional changes between T0-T1 and T1-T2 will be assessed in the MARPE group.
Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Expert Assessment of Perceived Facial Changes
Lasso di tempo: Baseline (T0) to 3 months after active expansion (T2).

Blinded orthodontic experts will evaluate paired three-dimensional facial images to assess the perceptibility and magnitude of facial changes. Assessments will include identification of the later time point, confidence level (0-10), perceived change severity (0-4), and facial regions showing the most noticeable changes.
Baseline (T0) to 3 months after active expansion (T2).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-Reported Perception of Facial Changes
Lasso di tempo: 3 months after active expansion (T2).

Participants will complete a self-assessment questionnaire to evaluate their perceived facial changes following MARPE treatment. Patient-reported perceptions will be assessed and compared with objectively measured three-dimensional facial soft tissue changes.
3 months after active expansion (T2).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Adiyaman University

Investigatori

  • Investigatore principale: Nihal HAMAMCI, Professor Doctor, Adiyaman University
  • Direttore dello studio: Hasan Kılınç, research assistant, Adiyaman University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

29 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 settembre 2026

Primo Inserito (Effettivo)

5 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • ADIYAMAN-MARPE-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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