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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Sofia Lobo, Masters contact

+351917789540

slobo@egasmoniz.edu.pt

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:

  1. 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:

    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.

Study groups in NCT07016048
Study groupRoleWhat they receive
Static occlusionPlacebo comparatorUse 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 comparatorUse 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 comparatorUse 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 articulatorActive comparatorUse 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.

  1. 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)
  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.

  1. First posted11 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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

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.

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