3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction
5 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
22
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Cairo, Egipt
- Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University
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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
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
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: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Clinical Appointments to Complete the Prosthetic Phase
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
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 (Rzeczywisty)
31 października 2024
Zakończenie podstawowe (Rzeczywisty)
1 września 2025
Ukończenie studiów (Rzeczywisty)
25 lipca 2026
Daty rejestracji na studia
Pierwszy przesłany
1 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
7 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
7 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- FDASU-Rec IR/M102515
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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