Edentulous Complete Denture WearersNCT07898332
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
A study testing Face scan in people with Edentulous Complete Denture Wearers, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The purpose of this study is to evaluate if a 3D face scanner is a reliable and accurate tool for measuring the vertical dimension of occlusion (the optimal height of the lower face) in patients who have lost all their teeth. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Edentulous Complete Denture Wearers
- What is being tested?
- Face scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Nov 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous in both the maxilla and mandible.
- Willing and able to provide informed consent.
- Rehabilitated with complete dentures as part of the study protocol.
Who cannot join
- Patients suffering from any Temporomandibular Joint Dysfunction (TMD).
- Patients with any visible facial abnormality.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Egyptian Russian University
Cairo, Nasr City
Hanan Ali Mohamed, PHD, 01033110557 ext. +2, hanan-alimohamed@eru.edu.eg
- Recruiting
Egyptian Russian University
Cairo
Hanan A Mohamed, PHD, 01033110557 ext. +2, hanan-alimohamed@eru.edu.eg
About this study
Official title: Comparative Evaluation of Conventional and Face Scan Techniques in Recording the Vertical Dimension of Occlusion in Completely Edentulous Cases
The purpose of this study is to evaluate if a 3D face scanner is a reliable and accurate tool for measuring the vertical dimension of occlusion (the optimal height of the lower face) in patients who have lost all their teeth.
Currently, dentists determine this measurement manually using clinical judgment, which can sometimes lead to inconsistent results. This study will compare the traditional manual measurement method with a digital face scanning technique.
Eighteen completely edentulous (toothless) participants will be enrolled. Each participant will receive two sets of complete dentures: one set fabricated using the new digital face scanning technique and one set fabricated using the traditional method. Researchers will take facial measurements using both a digital caliper directly on the patient's face and a software tool on the 3D scans. The results will help determine if digital scanning is a dependable alternative to conventional methods for improving denture fit, function, and patient comfort.
Read the detailed description
Background and Rationale Accurate determination of the vertical dimension of occlusion (VDO) and vertical dimension at rest (VDR) is an important aspect of prosthodontic rehabilitation in completely edentulous patients. Conventional techniques rely on clinical assessment and direct facial measurements, which may be affected by clinician judgment and measurement variability. Three-dimensional facial scanning provides a non-contact method of recording facial morphology and may offer an alternative approach for measuring facial dimensions in complete denture patients.
Study Design and Participants This prospective, in vivo comparative study will include 18 completely edentulous participants requiring complete denture rehabilitation. Participants with temporomandibular joint dysfunction or visible facial abnormalities will be excluded. Each participant will receive two sets of complete dentures: one fabricated using a digital workflow involving facial scanning and another fabricated using the conventional technique.
Facial Landmarks and Measurement Procedures Facial landmarks will be identified on the participant's face and marked using a conventional marker before the measurement procedures.
Assessment of the vertical dimension of occlusion, and vertical dimension at rest will be done.
Each participant will undergo two facial scanning procedures under standardized conditions, following the manufacturer's recommendations and procedures described in previous publications. The resulting three-dimensional facial scan data will be saved in Standard Tessellation Language (STL) format.
Conventional and Digital Measurements Conventional facial measurements will be obtained directly from the participant's face using a digital Vernier caliper. For digital measurements, the facial scan files will be imported into mesh-processing software. The selected facial landmarks will be identified on the digital models, and measurements will be obtained using the software's built-in measurement tool.
Measurements obtained using the conventional and digital techniques will be compared to evaluate the agreement between the two methods for recording the vertical dimension of occlusion and the vertical dimension at rest.
Outcome Evaluation The study will assess the accuracy and reliability of facial scanning for recording the vertical dimension of occlusion compared with conventional direct facial measurements. The collected measurements will be analyzed statistically to evaluate the differences and agreement between the two techniques.
Ethical Considerations Participants will be informed about the study procedures and expected risks before participation, and written informed consent will be obtained. Participant information and study data will be kept confidential and stored on a password-protected computer, with each participant's data maintained in a separate file. Any adverse events will be reported to the study supervisors and the relevant ethics committee.
- Conditions
- Edentulous Complete Denture Wearers
- Being tested
- Face scan
- Keywords
- Vertical dimension, Face scan, Complete denture, Prosthetic rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face scanDevice
Soft-tissue facial landmarks will be marked on the patient. A face scanner will be used to acquire 3D facial models in (VDO) and (VDR). The STL scans will be imported into mesh processing software for digital measurements.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | A single group of 18 completely edentulous patients. Each participant will receive two complete dentures (one digitally fabricated and one conventionally fabricated) to allow for a within-subject comparison of the two measurement techniques. Receives: Device: Face scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy digital face scan in vertical Dimension of Occlusion Measurements
The accuracy and reliability of the face scanning technique will be evaluated by comparing digital measurements obtained from 3D facial scans . The specific measurements will be the distances between marked soft-tissue facial landmarks in (VDO) and at rest (VDR).
Measured: Baseline to 2 months (measured immediately after denture fabrication and scan acquisition).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Complete Denture WearersStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of 18 edentulous patients. Each participant will receive both a digitally fabricated denture and a conventionally fabricated denture to compare the accuracy of face scanning versus conventional methods for measuring the vertical dimension of occlusion."
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898332
- Sponsor's protocol ID
- 53
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Conventional and Face Scan Techniques in Recording the Vertical Dimension of Occlusion in Completely Edentulous Cases
- ClinicalTrials.gov ID
- NCT07898332
- Acronym / sponsor ID
- 53
- Conditions
- Edentulous Complete Denture Wearers
- Keywords
- Vertical dimension, Face scan, Complete denture, Prosthetic rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Oct 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.
The purpose of this study is to evaluate if a 3D face scanner is a reliable and accurate tool for measuring the vertical dimension of occlusion (the optimal height of the lower face) in patients who have lost all their teeth.
Currently, dentists determine this measurement manually using clinical judgment, which can sometimes lead to inconsistent results. This study will compare the traditional manual measurement method with a digital face scanning technique.
Eighteen completely edentulous (toothless) participants will be enrolled. Each participant will receive two sets of complete dentures: one set fabricated using the new digital face scanning technique and one set fabricated using the traditional method. Researchers will take facial measurements using both a digital caliper directly on the patient's face and a software tool on the 3D scans. The results will help determine if digital scanning is a dependable alternative to conventional methods for improving denture fit, function, and patient comfort.
Detailed description
Background and Rationale Accurate determination of the vertical dimension of occlusion (VDO) and vertical dimension at rest (VDR) is an important aspect of prosthodontic rehabilitation in completely edentulous patients. Conventional techniques rely on clinical assessment and direct facial measurements, which may be affected by clinician judgment and measurement variability. Three-dimensional facial scanning provides a non-contact method of recording facial morphology and may offer an alternative approach for measuring facial dimensions in complete denture patients.
Study Design and Participants This prospective, in vivo comparative study will include 18 completely edentulous participants requiring complete denture rehabilitation. Participants with temporomandibular joint dysfunction or visible facial abnormalities will be excluded. Each participant will receive two sets of complete dentures: one fabricated using a digital workflow involving facial scanning and another fabricated using the conventional technique.
Facial Landmarks and Measurement Procedures Facial landmarks will be identified on the participant's face and marked using a conventional marker before the measurement procedures.
Assessment of the vertical dimension of occlusion, and vertical dimension at rest will be done.
Each participant will undergo two facial scanning procedures under standardized conditions, following the manufacturer's recommendations and procedures described in previous publications. The resulting three-dimensional facial scan data will be saved in Standard Tessellation Language (STL) format.
Conventional and Digital Measurements Conventional facial measurements will be obtained directly from the participant's face using a digital Vernier caliper. For digital measurements, the facial scan files will be imported into mesh-processing software. The selected facial landmarks will be identified on the digital models, and measurements will be obtained using the software's built-in measurement tool.
Measurements obtained using the conventional and digital techniques will be compared to evaluate the agreement between the two methods for recording the vertical dimension of occlusion and the vertical dimension at rest.
Outcome Evaluation The study will assess the accuracy and reliability of facial scanning for recording the vertical dimension of occlusion compared with conventional direct facial measurements. The collected measurements will be analyzed statistically to evaluate the differences and agreement between the two techniques.
Ethical Considerations Participants will be informed about the study procedures and expected risks before participation, and written informed consent will be obtained. Participant information and study data will be kept confidential and stored on a password-protected computer, with each participant's data maintained in a separate file. Any adverse events will be reported to the study supervisors and the relevant ethics committee.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of 18 edentulous patients. Each participant will receive both a digitally fabricated denture and a conventionally fabricated denture to compare the accuracy of face scanning versus conventional methods for measuring the vertical dimension of occlusion."
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Face scanA single group of 18 completely edentulous patients. Each participant will receive two complete dentures (one digitally fabricated and one conventionally fabricated) to allow for a within-subject comparison of the two measurement techniques. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous in both the maxilla and mandible.
- Willing and able to provide informed consent.
- Rehabilitated with complete dentures as part of the study protocol.
Key exclusion criteria (2 listed)
- Patients suffering from any Temporomandibular Joint Dysfunction (TMD).
- Patients with any visible facial abnormality.
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 |
|---|---|---|
| Face scanSoft-tissue facial landmarks will be marked on the patient. A face scanner will be used to acquire 3D facial models in (VDO) and (VDR). The STL scans will be imported into mesh processing software for digital measurements. | Device | All participants |
Primary outcome
Accuracy digital face scan in vertical Dimension of Occlusion Measurements
Time frame: Baseline to 2 months (measured immediately after denture fabrication and scan acquisition).
The accuracy and reliability of the face scanning technique will be evaluated by comparing digital measurements obtained from 3D facial scans . The specific measurements will be the distances between marked soft-tissue facial landmarks in (VDO) and at rest (VDR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Edentulous Complete Denture Wearers
Not yet recruiting
Digital vs Conventional Prosthetic Rehab & Occlusal Analysis in Edentulous Patients
Edentulous Complete Denture Wearers, Dental Occlusion
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face scan in people with Edentulous Complete Denture Wearers, run by Ain Shams University at 2 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanan A Mohamed, BDS, MDS, PhD (01033110557 ext. +2, hanan-alimohamed@eru.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy digital face scan in vertical Dimension of Occlusion Measurements (time frame: Baseline to 2 months (measured immediately after denture fabrication and scan acquisition).). 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 30 Oct 2026.