Digital Technologies in Dental Rehabilitation PlanningPHDSLNCT07016048
Digital Technologies in Dental Rehabilitation Planning.
A study testing Try-in of one crown test with a digital wax-up (per group) in people with Digital Technologies in Dental Rehabilitation Planning, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.
Trial summary
The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Digital Technologies in Dental Rehabilitation Planning
- What is being tested?
- Try-in of one crown test with a digital wax-up (per group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who require rehabilitation with a single crown;
- The tooth to be rehabilitated must have an opponent to test the occlusion.
Who cannot join
- The tooth to be rehabilitated must does not have an opponent to test the occlusion;
- Edentulous patient;
- Incapable of understanding and/or giving consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Facial Scanning and Computerized Tomography as Aids in Single-tooth Rehabilitation Planning
The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown.
After collecting the patients, at the first appointment, data collection will be carried out, including: an intraoral scan (digital impressions), intraoral and extraoral photographs, CBCT, and facial scanning.
Read more
At the following appointment, a mock-up will be performed. The purpose of the mock-up is to preview the expected smile outcome before beginning the oral rehabilitation treatment.
After each mock-up, patients will be asked to complete a questionnaire designed to evaluate their self-perception of comfort and aesthetics.
Additionally, after each mock-up, the clinician will assess occlusal contacts (the bite) and record the time required for adjustments to achieve a comfortable occlusion for the patient.
The main questions it aims to answer are:
- How does the patient perceive comfort and aesthetics during the rehabilitation process?
- What is the influence of using a virtual articulator on diagnostic waxing accuracy?
- How does integrating facial scanning (FS) and cone-beam computed tomography (CBCT) affect current digital workflows involving a virtual articulator?
- What impact does the programming of the virtual articulator have on treatment planning outcomes?
Read the detailed description
The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown, with aims:
- assessing patient's comfort and aesthetics self-perception; ii) evaluate the influence of a virtual articulator in a diagnostic waxing; iii) evaluate the influence of implementation of FS and CBCT to the current digital procedure with a virtual articulator; iv) evaluate the influence of programming the virtual articulator.
Data collection will be carried out in participants, including: an intraoral scan (digital impressions), intraoral and extraoral photographs (DPhotos), CBCT, and facial scan.
In a CAD/CAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.
The digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.
The design and occlusal adjustment of the crown will carry out in four different ways, separating them into the following groups:
- Group 1: IOS + DPhotos - Diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do).
- Group 2: IOS + DPhotos - Set up the models in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values.
- Group 3: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the program's default and standard values.
- Group 4: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans.
For the representation of the Group 4, we will program a virtual articulator by modifying the values of the condylar guidance angles, in order to realize the changes that could occur just by modifying them. During the study, we plan to program the articulator with dynamic scans of each patient. These dynamic scans will result in individually customised condylar guidance angles.
Four crown tests will be produced, one for each group, to enable them to be tried out on participants (like a mock-up).
Participants enrolled in this study will be randomly allocated in the 4 groups, with a computer-generated randomization list (https://www.randomizer.org/).
Allocation concealment will be performed using sealed and opaque numbered envelopes which were opened by the dentist immediately before the mock-up.
All the procedures will be performed by one experienced clinician.
The steps of clinical procedure are:
Step 1 - In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses.
Step 2 - Digital impressions, and a model of the teeth will be done. Step 3 - Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models.
Step 4 - Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth.
We will evaluate the volumetric difference (in micrometers) before and after occlusal adjustments, in each group; and the volumetric difference between the diagnostic wax-ups obtained in each group.
After each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale.
- Being tested
- Try-in of one crown test with a digital wax-up (per group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Try-in of one crown test with a digital wax-up (per group)Procedure or surgery
In a CAD/CAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.
The digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.
The steps of clinical procedure are:
- - In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses.
- - Digital impressions, and a model of the teeth will be done.
- - Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models.
- - Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth.
We will evaluate the volumetric difference between the diagnostic wax-ups obtained in each group.
After each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale.
| Study group | Role | What they receive |
|---|---|---|
| Static occlusion | Placebo comparator | Use IOS + DPhotos - Set up the models and do a diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do). Receives: Procedure: Try-in of one crown test with a digital wax-up (per group) |
| Virtual articulator (standard values) | Active comparator | Use IOS + DPhotos - Set up the models do a diagnostic waxing in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values. Receives: Procedure: Try-in of one crown test with a digital wax-up (per group) |
| Virtual articulator with CBCT and FS (standard values) | Active comparator | Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the program's default and standard values. Receives: Procedure: Try-in of one crown test with a digital wax-up (per group) |
| Programmed virtual articulator | Active comparator | Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans. Receives: Procedure: Try-in of one crown test with a digital wax-up (per group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences before and after occlusal adjustments
The primary outcome is the volumetric difference (in micrometers) before and after occlusal adjustments, in each group.
Measured: From enrollment to the end of treatment (8 weeks)
Secondary outcomes (1)
Patients's aesthetics and comfort self-perception
The secondary outcome measure is the patient's comfort and aesthetics self-perception - with questionnaires, using a numerical scale.
Measured: From enrollment to the end of treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Technologies in Dental Rehabilitation PlanningStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016048
- Sponsor's protocol ID
- 1409
- Acronym
- PHDSL
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Scanning and Computerized Tomography as Aids in Single-tooth Rehabilitation Planning
- ClinicalTrials.gov ID
- NCT07016048
- Acronym / sponsor ID
- PHDSL / 1409
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 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.
The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown.
After collecting the patients, at the first appointment, data collection will be carried out, including: an intraoral scan (digital impressions), intraoral and extraoral photographs, CBCT, and facial scanning.
At the following appointment, a mock-up will be performed. The purpose of the mock-up is to preview the expected smile outcome before beginning the oral rehabilitation treatment.
After each mock-up, patients will be asked to complete a questionnaire designed to evaluate their self-perception of comfort and aesthetics.
Additionally, after each mock-up, the clinician will assess occlusal contacts (the bite) and record the time required for adjustments to achieve a comfortable occlusion for the patient.
The main questions it aims to answer are:
- How does the patient perceive comfort and aesthetics during the rehabilitation process?
- What is the influence of using a virtual articulator on diagnostic waxing accuracy?
- How does integrating facial scanning (FS) and cone-beam computed tomography (CBCT) affect current digital workflows involving a virtual articulator?
- What impact does the programming of the virtual articulator have on treatment planning outcomes?
Detailed description
The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown, with aims:
- assessing patient's comfort and aesthetics self-perception; ii) evaluate the influence of a virtual articulator in a diagnostic waxing; iii) evaluate the influence of implementation of FS and CBCT to the current digital procedure with a virtual articulator; iv) evaluate the influence of programming the virtual articulator.
Data collection will be carried out in participants, including: an intraoral scan (digital impressions), intraoral and extraoral photographs (DPhotos), CBCT, and facial scan.
In a CAD/CAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.
The digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.
The design and occlusal adjustment of the crown will carry out in four different ways, separating them into the following groups:
- Group 1: IOS + DPhotos - Diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do).
- Group 2: IOS + DPhotos - Set up the models in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values.
- Group 3: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the program's default and standard values.
- Group 4: IOS + DPhotos + CBCT + FS - Set up the models in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans.
For the representation of the Group 4, we will program a virtual articulator by modifying the values of the condylar guidance angles, in order to realize the changes that could occur just by modifying them. During the study, we plan to program the articulator with dynamic scans of each patient. These dynamic scans will result in individually customised condylar guidance angles.
Four crown tests will be produced, one for each group, to enable them to be tried out on participants (like a mock-up).
Participants enrolled in this study will be randomly allocated in the 4 groups, with a computer-generated randomization list (https://www.randomizer.org/).
Allocation concealment will be performed using sealed and opaque numbered envelopes which were opened by the dentist immediately before the mock-up.
All the procedures will be performed by one experienced clinician.
The steps of clinical procedure are:
Step 1 - In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses.
Step 2 - Digital impressions, and a model of the teeth will be done. Step 3 - Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models.
Step 4 - Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth.
We will evaluate the volumetric difference (in micrometers) before and after occlusal adjustments, in each group; and the volumetric difference between the diagnostic wax-ups obtained in each group.
After each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Static occlusion | Placebo comparator | Procedure: Try-in of one crown test with a digital wax-up (per group)Use IOS + DPhotos - Set up the models and do a diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do). |
| Virtual articulator (standard values) | Active comparator | Procedure: Try-in of one crown test with a digital wax-up (per group)Use IOS + DPhotos - Set up the models do a diagnostic waxing in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values. |
| Virtual articulator with CBCT and FS (standard values) | Active comparator | Procedure: Try-in of one crown test with a digital wax-up (per group)Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the program's default and standard values. |
| Programmed virtual articulator | Active comparator | Procedure: Try-in of one crown test with a digital wax-up (per group)Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who require rehabilitation with a single crown;
- The tooth to be rehabilitated must have an opponent to test the occlusion.
Key exclusion criteria (3 listed)
- The tooth to be rehabilitated must does not have an opponent to test the occlusion;
- Edentulous patient;
- Incapable of understanding and/or giving consent.
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 |
|---|---|---|
| Try-in of one crown test with a digital wax-up (per group)In a CAD/CAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models. The digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups. The steps of clinical procedure are: 1. - In the first appointment, the patients mention their smile concerns, and the dentist evaluate and diagnoses. 2. - Digital impressions, and a model of the teeth will be done. 3. - Diagnostic wax-up, where dentist and dental laboratory plan the wax-up on the study models. 4. - Diagnostic mock-up, where dentist transfers the diagnostic wax-up to the patient's mouth. We will evaluate the volumetric difference between the diagnostic wax-ups obtained in each group. After each mock-up, a questionnaire will be delivered to the patients in order to assess patients's aesthetics and comfort self-perception, using a numeric scale. | Procedure or surgery | Programmed virtual articulator, Static occlusion, Virtual articulator (standard values), Virtual articulator with CBCT and FS (standard values) |
Primary outcome
Differences before and after occlusal adjustments
Time frame: From enrollment to the end of treatment (8 weeks)
The primary outcome is the volumetric difference (in micrometers) before and after occlusal adjustments, in each group.
1 secondary outcome
Patients's aesthetics and comfort self-perception
Time frame: From enrollment to the end of treatment (8 weeks)
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 11 Jun 2025.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
A study testing Try-in of one crown test with a digital wax-up (per group) in people with Digital Technologies in Dental Rehabilitation Planning, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Sofia Lobo, Masters (+351917789540, slobo@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences before and after occlusal adjustments (time frame: From enrollment to the end of treatment (8 weeks)). 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 11 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.