Dental Implant-Supported Prosthesis, Full-Arch Edentulism, Maxillofacial Prosthesis
Conditions
Keywords
3D facial scanning, digital workflow, jaw-relation recording, full-arch rehabilitation, dental implants, OHIP-14, patient-reported outcomes, time efficiency
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREConventional-Digital Jaw-Relation Workflow
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
PROCEDURE3D Facial Scanning-Guided Jaw-Relation Workflow
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint | 4 weeks | 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). |
| Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint | 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinical Appointments to Complete the Prosthetic Phase | up to 12 weeks | Total number of clinic visits from jaw-relation registration through prosthesis delivery. |
| Number of Try-In Adjustments | up to 8 weeks | Number of chairside occlusal corrections (selective grinding, material addition, or jaw-relation re-verification) required at try-in before definitive fabrication. |
| Implant and Prosthesis Survival / Complications at 6 Months | 6 months post-delivery | Clinical review for implant failure, prosthesis fracture, or other mechanical/biological complications. |
Countries
Egypt
Outcome results
None listed