Occlusal AnalysisNCT06846372
3D Integration of Facial , Intraoral Scanning and CBCT on Patient Satisfaction and Occlusion of Temporary, Permanent Implant Supported Prosthesis
A study testing occluscence and patient satisfaction in people with Occlusal Analysis and Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will aim to evaluate the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occlusal Analysis, Patient Satisfaction
- What is being tested?
- occluscence and patient satisfaction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 May 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy individuals with the completely edentulous maxilla and mandible rehabilitated by six implants.
Who cannot join
- individuals with uncontrolled systemic diseases that affect the success of implant survival rate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 3D Integration of Facial Scanning, Intraoral Scanning and CBCT On Patient Satisfaction and Occlusion of Temporary and Permanent Full Arch Implant Supported Prosthesis
This study will aim to evaluate the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.
Read the detailed description
Aim: evaluating the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.
Methods:1. Four radio opaque markers on patient's face will be placed. The first facial scan will be done (FS1) using a facial scanner (Bellus3D mobile application) while the patient is smiling.
2.A proper size of triple tray will be selected and adjusted if needed, and the impression material will be kept to the minimum required to avoid any overextension that can cause forced soft tissue displacement. The handle will be removed and 3 markers will be placed on the front of the triple tray.
3- The tray will be filled with heavy body vinylpolysiloxane (VPS) material and inserted in patient's mouth. The patient will be instructed to close in habitual occlusion and the second facial scan (FS2) will be taken with the head in the same position.
- Both facial scans will be imported to a dental software design program as STL1 and STL2 files, respectively. A CBCT will be taken while the markers are still in place. Through the face scans and CBCT scan, make sure the patient is in a natural head position where reference lines (Frankfurt plane and occlusal plane) are confirmed to be parallel to the floor. The patient will be instructed to stay still.
- The maxillary and mandibular intraoral scans will be taken with jaw relation record (STL3) using an intraoral scanner and scan the triple tray on both sides and external borders with markers in place using the Bio copy tool in Prime scan (STL4).
- All scans will be exported to the design software. and use the design module of CAD software to superimpose the facial scans (STL1 and STL2) by using markers as reference points 7.The intraoral scans will be integrated to facial scans by using the inter arch impression STL4 (Scan of triple tray or Bio copy) as a merging tool. Complete the facially generated diagnostic wax up (STL5).
- The completed maxillary diagnostic wax up (STL5) will be exported, pre op intraoral scans (STL3) and will be imported to implant planning software using STL markers to merge STL files correctly. the STL files with CBCT will be merged, and the interim restoration will be designed in the software program and it will be 3D printed.
9.the interim restoration will be inserted and the patient satisfaction and occlusion will be evaluated.
- The patient will receive postoperative instructions until the definitive prostheses will be fabricated.
11.After insertion of the permanent restoration the patient satisfaction and occlusion will be evaluated.
Evaluation:• Occlusal analysis will be evaluated by occluo-scence (measuring the balance of occlusal contact forces, the sequence, strength, and density of the occlusal contacts The patient's recorded occlusal information will be transmitted and displayed on the app.
- patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent).
Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?
- Conditions
- Occlusal Analysis, Patient Satisfaction
- Being tested
- occluscence, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occluscenceDevice
The OccluSense handheld is a battery powered device which uses your local wireless network to transmit the recorded data to the OccluSense-iPad-App.
The inductive charger provides wireless power transfer. Fully charged batteries allow up to 4 hours usage of the device.
patient satisfactionOther
- patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent).
Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?
| Study group | Role | What they receive |
|---|---|---|
| Temporary full arch implant supported prosthesis. | Active comparator | full arch temporary implant supported prosthesis will be fabricated for the first group using PMMA material Receives: Device: occluscence; Other: patient satisfaction |
| permanent full arch implant supported prosthesis. | Active comparator | Permanent full arch implant supported prosthesis will be fabricated for the second group from zirconia Receives: Device: occluscence; Other: patient satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusion of temporary and permanent full arch implant supported prosthesis constructed by digital workflow
Measured: "through study completion, an average of 1 year"
Secondary outcomes (1)
patient satisfaction of temporary and permanent full arch implant supported prosthesis constructed by digital workflow using (vas score)
- patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent).
Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occlusal AnalysisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mostafa Abdo El Syad, Professor, Principal investigator, faculty of dentistry Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846372
- Sponsor's protocol ID
- A04012023RP
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kuhlman DC, Almuzian M, Coppini C, Alzoubi EE. Accuracy (trueness and precision) of four tablet-based applications for three-dimensional facial scanning: An in-vitro study. J Dent. 2023 Aug;135:104533. doi: 10.1016/j.jdent.2023.104533. Epub 2023 May 4.
PubMed 37149254
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3D Integration of Facial Scanning, Intraoral Scanning and CBCT On Patient Satisfaction and Occlusion of Temporary and Permanent Full Arch Implant Supported Prosthesis
- ClinicalTrials.gov ID
- NCT06846372
- Acronym / sponsor ID
- A04012023RP
- Conditions
- Occlusal Analysis, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Feb 2025 (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 will aim to evaluate the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.
Detailed description
Aim: evaluating the effect of complete digital workflow for construction of temporary and permanent full arch implant supported screw retained restoration by the 3D integration of facial scanning, intraoral scanning and CBCT regarding patient satisfaction (VAS score) and occlusion.
Methods:1. Four radio opaque markers on patient's face will be placed. The first facial scan will be done (FS1) using a facial scanner (Bellus3D mobile application) while the patient is smiling.
2.A proper size of triple tray will be selected and adjusted if needed, and the impression material will be kept to the minimum required to avoid any overextension that can cause forced soft tissue displacement. The handle will be removed and 3 markers will be placed on the front of the triple tray.
3- The tray will be filled with heavy body vinylpolysiloxane (VPS) material and inserted in patient's mouth. The patient will be instructed to close in habitual occlusion and the second facial scan (FS2) will be taken with the head in the same position.
- Both facial scans will be imported to a dental software design program as STL1 and STL2 files, respectively. A CBCT will be taken while the markers are still in place. Through the face scans and CBCT scan, make sure the patient is in a natural head position where reference lines (Frankfurt plane and occlusal plane) are confirmed to be parallel to the floor. The patient will be instructed to stay still.
- The maxillary and mandibular intraoral scans will be taken with jaw relation record (STL3) using an intraoral scanner and scan the triple tray on both sides and external borders with markers in place using the Bio copy tool in Prime scan (STL4).
- All scans will be exported to the design software. and use the design module of CAD software to superimpose the facial scans (STL1 and STL2) by using markers as reference points 7.The intraoral scans will be integrated to facial scans by using the inter arch impression STL4 (Scan of triple tray or Bio copy) as a merging tool. Complete the facially generated diagnostic wax up (STL5).
- The completed maxillary diagnostic wax up (STL5) will be exported, pre op intraoral scans (STL3) and will be imported to implant planning software using STL markers to merge STL files correctly. the STL files with CBCT will be merged, and the interim restoration will be designed in the software program and it will be 3D printed.
9.the interim restoration will be inserted and the patient satisfaction and occlusion will be evaluated.
- The patient will receive postoperative instructions until the definitive prostheses will be fabricated.
11.After insertion of the permanent restoration the patient satisfaction and occlusion will be evaluated.
Evaluation:• Occlusal analysis will be evaluated by occluo-scence (measuring the balance of occlusal contact forces, the sequence, strength, and density of the occlusal contacts The patient's recorded occlusal information will be transmitted and displayed on the app.
- patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent).
Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporary full arch implant supported prosthesis. | Active comparator | Device: occluscence, Other: patient satisfactionfull arch temporary implant supported prosthesis will be fabricated for the first group using PMMA material |
| permanent full arch implant supported prosthesis. | Active comparator | Device: occluscence, Other: patient satisfactionPermanent full arch implant supported prosthesis will be fabricated for the second group from zirconia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals with the completely edentulous maxilla and mandible rehabilitated by six implants.
Key exclusion criteria (1 listed)
- individuals with uncontrolled systemic diseases that affect the success of implant survival rate
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 |
|---|---|---|
| occluscenceThe OccluSense handheld is a battery powered device which uses your local wireless network to transmit the recorded data to the OccluSense-iPad-App. The inductive charger provides wireless power transfer. Fully charged batteries allow up to 4 hours usage of the device. | Device | Temporary full arch implant supported prosthesis., permanent full arch implant supported prosthesis. |
| patient satisfaction• patient satisfaction will be evaluated by using (VAS score) on a line from 0 to 100mm (0 mm is very bad /100 mm is excellent). Are you satisfied with the esthetic outcome of the treatment? Does the treatment answer to your expectations? Would you choose the same treatment again? Is your ability to chew improved after placement of the implant prothesis? Did you find the complete treatment time too prolonged? | Other | Temporary full arch implant supported prosthesis., permanent full arch implant supported prosthesis. |
Primary outcome
occlusion of temporary and permanent full arch implant supported prosthesis constructed by digital workflow
Time frame: "through study completion, an average of 1 year"
1 secondary outcome
patient satisfaction of temporary and permanent full arch implant supported prosthesis constructed by digital workflow using (vas score)
Time frame: "through study completion, an average of 1 year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Results publication: PubMed 37149254Kuhlman DC, Almuzian M, Coppini C, Alzoubi EE. Accuracy (trueness and precision) of four tablet-based applications for three-dimensional facial scanning: An in-vitro study. J Dent. 2023 Aug;135:104533. doi: 10.1016/j.jdent.2023.104533. Epub 2023 May 4.
- Individual participant dataSharing planned: No
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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.
Mostafa Abdo El Syad, Professor principal investigator
faculty of dentistry Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occluscence and patient satisfaction in people with Occlusal Analysis and Patient Satisfaction, run by Mansoura 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2025. 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?
Results are not available in the source record.
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?
occlusion of temporary and permanent full arch implant supported prosthesis constructed by digital workflow (time frame: "through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846372, which also lists 1 linked publication.
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 26 Feb 2025.