Full-Arch EdentulismNCT07751900
3D Facial Scanning in Full-Arch Implant Prosthodontics: Time Efficiency and Patient Satisfaction
A study testing Conventional-Digital Jaw-Relation Workflow and 3D Facial Scanning-Guided Jaw-Relation Workflow in people with Full-Arch Edentulism and Dental Implant-Supported Prosthesis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full-Arch Edentulism, Dental Implant-Supported Prosthesis, Maxillofacial Prosthesis
- What is being tested?
- Conventional-Digital Jaw-Relation Workflow and 3D Facial Scanning-Guided Jaw-Relation Workflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2024to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University
Cairo
About this study
Official title: 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.
Read the 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.
- Being tested
- Conventional-Digital Jaw-Relation Workflow, 3D Facial Scanning-Guided Jaw-Relation Workflow
- Keywords
- 3D facial scanning, digital workflow, jaw-relation recording, full-arch rehabilitation, dental implants, OHIP-14, patient-reported outcomes, time efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional-Digital Jaw-Relation WorkflowProcedure or surgery
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
3D Facial Scanning-Guided Jaw-Relation WorkflowProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional-Digital Hybrid Workflow | Active comparator | 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. Receives: Procedure: Conventional-Digital Jaw-Relation Workflow |
| Enhanced Digital Workflow with 3D Facial Scanning | Experimental | 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. Receives: Procedure: 3D Facial Scanning-Guided Jaw-Relation Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
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).
Measured: 4 weeks
Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint
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).
Measured: 4 weeks
Secondary outcomes (3)
Number of Clinical Appointments to Complete the Prosthetic Phase
Total number of clinic visits from jaw-relation registration through prosthesis delivery.
Measured: up to 12 weeks
Number of Try-In Adjustments
Number of chairside occlusal corrections (selective grinding, material addition, or jaw-relation re-verification) required at try-in before definitive fabrication.
Measured: up to 8 weeks
Implant and Prosthesis Survival / Complications at 6 Months
Clinical review for implant failure, prosthesis fracture, or other mechanical/biological complications.
Measured: 6 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start31 Oct 2024
- Primary completion1 Sep 2025
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full-Arch EdentulismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Farouk, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751900
- Sponsor's protocol ID
- FDASU-Rec IR/M102515
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrating 3D Facial Scanning in Full-Arch Implant Prosthetics: Time Efficiency and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07751900
- Acronym / sponsor ID
- FDASU-Rec IR/M102515
- Keywords
- 3D facial scanning, digital workflow, jaw-relation recording, full-arch rehabilitation, dental implants, OHIP-14, patient-reported outcomes, time efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional-Digital Hybrid Workflow | Active comparator | Procedure: Conventional-Digital Jaw-Relation Workflowaw-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. |
| Enhanced Digital Workflow with 3D Facial Scanning | Experimental | Procedure: 3D Facial Scanning-Guided Jaw-Relation WorkflowSame 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional-Digital Jaw-Relation WorkflowJaw-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 | Procedure or surgery | Conventional-Digital Hybrid Workflow |
| 3D Facial Scanning-Guided Jaw-Relation WorkflowIntegration 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. | Procedure or surgery | Enhanced Digital Workflow with 3D Facial Scanning |
Primary outcome
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).
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).
3 secondary outcomes
Number of Clinical Appointments to Complete the Prosthetic Phase
Time frame: up to 12 weeks
Number of Try-In Adjustments
Time frame: up to 8 weeks
Implant and Prosthesis Survival / Complications at 6 Months
Time frame: 6 months post-delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional-Digital Jaw-Relation Workflow and 3D Facial Scanning-Guided Jaw-Relation Workflow in people with Full-Arch Edentulism and Dental Implant-Supported Prosthesis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.