3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction
Effect of Integrating 3D Facial Scanning in Full-Arch Implant Prosthetics: Time Efficiency and Patient Satisfaction
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 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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Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
Time Frame: 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).
|
4 weeks
|
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Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint
Time Frame: 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).
|
4 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Clinical Appointments to Complete the Prosthetic Phase
Time Frame: up to 12 weeks
|
Total number of clinic visits from jaw-relation registration through prosthesis delivery.
|
up to 12 weeks
|
|
Number of Try-In Adjustments
Time Frame: 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.
|
up to 8 weeks
|
|
Implant and Prosthesis Survival / Complications at 6 Months
Time Frame: 6 months post-delivery
|
Clinical review for implant failure, prosthesis fracture, or other mechanical/biological complications.
|
6 months post-delivery
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- FDASU-Rec IR/M102515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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