3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction
5 agosto 2026 aggiornato da: Lamiaa Farouk, Ain Shams University
Effect of Integrating 3D Facial Scanning in Full-Arch Implant Prosthetics: Time Efficiency and Patient Satisfaction
This study compares two ways of planning the bite (jaw-relation) stage of full-arch, implant-supported dental prosthesis treatment: a standard digital approach, and the same approach with the addition of 3D facial scanning, which lets the dental team plan the new teeth against a scan of the patient's own face.
The study measured how patients felt about their treatment using a validated questionnaire, and also tracked how many clinic visits and adjustments each approach needed.
Twenty-two patients took part, randomly assigned to one of the two approaches.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
Full-arch implant-supported prosthetic rehabilitation requires accurate jaw-relation recording, which determines both the functional relationship between the arches and the esthetic integration of the final prosthesis within the patient's face.
Conventional digital workflows rely on intraoral scanning and wax-rim jaw-relation techniques without reference to extraoral facial anatomy.
This prospective, randomized, single-center pilot trial compared a conventional-digital hybrid workflow (Group A) with an enhanced digital workflow incorporating 3D facial scanning (Group B) in patients undergoing full-arch, implant-supported maxillary prosthetic rehabilitation (All-on-6 configuration).
All patients received six implants placed using a fully guided surgical protocol with a stackable surgical guide, followed by an immediately loaded PMMA provisional prosthesis during a three-month osseointegration period.
Following healing, patients were randomly allocated (computer-generated sequence, allocation concealed by an independent third party) to Group A or Group B for the prosthetic (jaw-relation recording) phase.
In Group B, 3D facial scanning was merged with intraoral scans and CBCT data to guide prosthetic design against facial reference planes.
The primary outcome was patient-reported oral health-related quality of life, measured using the validated short-form Oral Health Impact Profile (OHIP-14) questionnaire, administered after four weeks of intraoral trial wear of the try-in prosthesis (T1) and again four weeks after delivery of the definitive prosthesis (T2).
Secondary outcomes included the number of clinical appointments and chairside adjustments required to complete the prosthetic phase, and implant/prosthesis survival at six months.
The definitive prosthesis in both groups consisted of a milled cobalt-chromium framework with layered zirconia, with a mutually protected occlusal scheme.
Outcome assessment (clinical/technical evaluation and statistical analysis) was blinded; blinding of patients and the treating clinician was not feasible given the visibly different nature of the two workflows.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
22
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Cairo, Egitto
- Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University
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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
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Adults (≥18 years) indicated for full-arch maxillary implant-supported fixed prosthetic rehabilitation
- Completion of the surgical phase with stable implant osseointegration
- Presence of healthy peri-implant soft tissues
- Adequate oral hygiene status
- Sufficient bone and soft-tissue conditions compatible with full-arch prosthetic rehabilitation
- Ability to comply with all scheduled follow-up visits
- Capacity to maintain natural head position during facial scanning procedures
- Absence of significant gag reflex interfering with scanning/impression procedures
- Ability to communicate effectively and complete questionnaires
- Provision of written informed consent
- Physically and psychologically fit for the planned treatment
Exclusion Criteria:
- Severe skeletal or orthognathic discrepancies
- History of significant facial trauma or surgery affecting facial symmetry
- Prior maxillofacial pathology affecting the surgical/prosthetic site
- Uncontrolled systemic diseases affecting healing or treatment tolerance
- Use of medications that alter osseointegration or facial soft tissues
- Active oral or peri-implant infection
- Neuromuscular disorders or temporomandibular joint dysfunction affecting jaw positioning
- Conditions affecting the ability to maintain stable head position for scanning
- Severe psychomotor limitations
- Known hypersensitivity to materials used in bite registration or prosthesis fabrication
- Inability or unwillingness to provide informed consent
- Pregnancy or lactation, if deemed a contraindication by the supervising clinician
- Poor compliance or demonstrated unreliability in past dental or medical care
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
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Conventional-Digital Hybrid Workflow
aw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, without facial scanning.
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Jaw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, w
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Sperimentale: Enhanced Digital Workflow with 3D Facial Scanning
Same base digital workflow as Group A, with the addition of high-resolution 3D facial scanning (Shining 3D structured-light scanner), merged with intraoral scans and CBCT data via Exocad software to guide prosthetic alignment against extraoral facial landmarks.
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Integration of 3D facial scanning into the jaw-relation recording stage of full-arch implant prosthetic rehabilitation, merging facial, intraoral, and CBCT datasets to guide prosthetic design against facial reference planes.
Performed in addition to the same base digital workflow described in Intervention 1.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
Lasso di tempo: 4 weeks
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Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse).
Assessed after the patient had worn the try-in (trial) prosthesis intraorally for four weeks (T1).
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4 weeks
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint
Lasso di tempo: 4 weeks
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Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse).
Assessed four weeks after delivery of the definitive prosthesis (T2).
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4 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Clinical Appointments to Complete the Prosthetic Phase
Lasso di tempo: up to 12 weeks
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Total number of clinic visits from jaw-relation registration through prosthesis delivery.
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up to 12 weeks
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Number of Try-In Adjustments
Lasso di tempo: up to 8 weeks
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Number of chairside occlusal corrections (selective grinding, material addition, or jaw-relation re-verification) required at try-in before definitive fabrication.
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up to 8 weeks
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Implant and Prosthesis Survival / Complications at 6 Months
Lasso di tempo: 6 months post-delivery
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Clinical review for implant failure, prosthesis fracture, or other mechanical/biological complications.
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6 months post-delivery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Effettivo)
31 ottobre 2024
Completamento primario (Effettivo)
1 settembre 2025
Completamento dello studio (Effettivo)
25 luglio 2026
Date di iscrizione allo studio
Primo inviato
1 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 agosto 2026
Primo Inserito (Effettivo)
7 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- FDASU-Rec IR/M102515
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared.
The original informed consent obtained from participants covered their participation in this study but did not include provisions for the public sharing of individual-level, de-identified data with third parties or external researchers.
In addition, given the small sample size (n = 11 per group) within a single department, there is a meaningful risk that even de-identified individual-level data could be re-identified.
No data-sharing repository or access infrastructure has been established for this dataset.
Aggregate, de-identified results are reported in the published thesis and any resulting publications.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .