Comparison Between Conventional and Digital Workflow in Dental Prosthesis

NCT ID: NCT06215781

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-07

Study Completion Date

2023-12-01

Brief Summary

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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

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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

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Dental Prosthesis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three-arms groups
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Fully digital workflow

Patients of this group are subjected to entire digital workflow, from the digital planning to the delivery of definitive zirconia fixed dental prosthesis

Group Type EXPERIMENTAL

Fully digital workflow of prosthetic fixed dental crown

Intervention Type PROCEDURE

The 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.

Combined digital-conventional workflows

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).

Group Type EXPERIMENTAL

Combined digital and conventional workflows of prosthetic fixed dental crown

Intervention Type PROCEDURE

The 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.

Fully conventional workflow

Patients of this group follow the entire analog protocol. All the procedures exclude digital involvement.

Group Type ACTIVE_COMPARATOR

Fully conventional workflow of prosthetic fixed dental crown

Intervention Type PROCEDURE

The 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.

Interventions

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Fully digital workflow of prosthetic fixed dental crown

The 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.

Intervention Type PROCEDURE

Combined digital and conventional workflows of prosthetic fixed dental crown

The 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.

Intervention Type PROCEDURE

Fully conventional workflow of prosthetic fixed dental crown

The 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Massimo Corsalini

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Corsalini, Prof.

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Department of Medicine, University of Bari "Aldo Moro"

Locations

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Massimo Corsalini

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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UOC Odontostomatologia

Identifier Type: -

Identifier Source: org_study_id

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