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Comparison Between Conventional and Digital Workflow in Dental Prosthesis

A

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status

Completed

Conditions

Dental Prosthesis Complication

Treatments

Procedure: Fully conventional workflow of prosthetic fixed dental crown
Procedure: Combined digital and conventional workflows of prosthetic fixed dental crown
Procedure: Fully digital workflow of prosthetic fixed dental crown

Study type

Interventional

Funder types

Other

Identifiers

NCT06215781
UOC Odontostomatologia

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • good oral health
  • good general health conditions
  • no contraindication to oral surgery and fixed prosthesis
  • patients who completed the 6 months follow-up

Exclusion criteria

  • bad oral health
  • bad general health conditions (with multi-drug therapy)
  • periodontitis or dental caries susceptibly
  • parafunctions presence
  • TMJ disorders
  • didn't accept the informed consent / treatment planning

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Fully digital workflow
Experimental group
Description:
Patients of this group are subjected to entire digital workflow, from the digital planning to the delivery of definitive zirconia fixed dental prosthesis
Treatment:
Procedure: Fully digital workflow of prosthetic fixed dental crown
Combined digital-conventional workflows
Experimental group
Description:
Patients of this group were subjected to every digital steps as the "fully digital workflow" arm, except for the impression that includes analog material (silicones).
Treatment:
Procedure: Combined digital and conventional workflows of prosthetic fixed dental crown
Fully conventional workflow
Active Comparator group
Description:
Patients of this group follow the entire analog protocol. All the procedures exclude digital involvement.
Treatment:
Procedure: Fully conventional workflow of prosthetic fixed dental crown

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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