Clinical Trials Directory

Trials / Completed

CompletedNCT06215781

Comparison Between Conventional and Digital Workflow in Dental Prosthesis

Comparison Between Conventional and Digital Workflow in Fixed Dental Prosthetic Rehabilitations: a Randomized Clinical Trial Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The aim of this comparative RCT is to evaluate the differences between the entire digital, the combined digital-analogic and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study. The 60 patients are divided into three groups: * fully digital workflow * combined digital and conventional workflow * fully conventional workflow For each patients were evaluated the interproximal (IC) and occlusal contact (OC) and impression time (IT) and the patient satisfaction through a VAS scale. The null hypothesis is that are no differences between the three groups for each parameter.

Detailed description

This comparative RCT aims to evaluate the differences between the entire digital, the combined digital-analogic, and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study to better focus on the reliability of digital techniques. Inclusion criteria were good oral health, absence of parafunction, no dental caries or presence of periodontitis, and healthy general conditions. Exclusion criteria were bad oral health, parafunctions, dental caries or periodontitis, and general health comorbidities that don't allow surgical treatment. The 60 patients are divided into three groups: * fully digital workflow: each patient in this group was treated with an exclusively digital workflow, from digital planning of the surgical phase to digital impression and digital manufacturing of prosthetic crowns. * combined digital and conventional workflow: each patient of this group was subjected to digital planning, and then, the impressions were taken with traditional analogical materials, so the plaster model was converted into a digital model, and there finally was performed a digital manufacturing of prosthetic crown. * entirely conventional workflow: each patient was treated with an analogical technique. No digital phase was performed. After prosthetic delivery, each patient were evaluated for interproximal (IC) and occlusal contact (OC), impression time (IT), and patient satisfaction through a VAS scale. The null hypothesis is that there are no significant differences between the three groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREFully digital workflow of prosthetic fixed dental crownThe intervention that was administered was a full digital workflow. It includes an initial digital planning, an optical impression with intraoral scanner and a CAD-CAM milled zirconia crown. No analog materials were used.
PROCEDURECombined digital and conventional workflows of prosthetic fixed dental crownThe intervention that was administered was a combined digital and traditional workflow. The initial planning was digital, then the impression was performed with analog impression material (silicones) and the final zirconia crown was CAD-CAM milled, with a digital procedure.
PROCEDUREFully conventional workflow of prosthetic fixed dental crownThe intervention that was administered was a conventional workflow that doesn't provide any digital step. The impression was taken with analog material (silicones) and the final prosthesis was a metal-ceramic crown, realized on plaster cast.

Timeline

Start date
2018-01-07
Primary completion
2023-09-01
Completion
2023-12-01
First posted
2024-01-22
Last updated
2024-01-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06215781. Inclusion in this directory is not an endorsement.