Digital Technologies in Dental Rehabilitation Planning.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who require rehabilitation with a single crown;
The tooth to be rehabilitated must have an opponent to test the occlusion.
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Try-in of one crown test with a digital wax-up (per group)
Procedure/SurgeryIn 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.
Treatment groups
25 Participants
are divided into 4 treatment groupsGroup A: Static occlusionPlacebo comparator 1 intervention
Group B: Virtual articulator (standard values)Active comparator 1 intervention
Group C: Virtual articulator with CBCT and FS (standard values)Active comparator 1 intervention
Group D: Programmed virtual articulatorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Differences before and after occlusal adjustments
The primary outcome is the volumetric difference (in micrometers) before and after occlusal adjustments, in each group.
Time frame
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.
Time frame
From enrollment to the end of treatment (8 weeks)Other outcomes
1
Occlusion differences between diagnostic wax-ups
Other outcome is the volumetric difference (in micrometers) between the diagnostic wax-ups obtained in each group.
Time frame
From enrollment to the end of treatment (8 weeks)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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