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

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.

Study Overview

• Status: Completed
• Conditions: Dental Prosthesis Complication
• Intervention / Treatment: Procedure: Fully digital workflow of prosthetic fixed dental crown; Procedure: Combined digital and conventional workflows of prosthetic fixed dental crown; Procedure: Fully conventional workflow of prosthetic fixed dental crown

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Massimo Corsalini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.
Experimental: 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).	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.
Active Comparator: Fully conventional workflow; Patients of this group follow the entire analog protocol. All the procedures exclude digital involvement.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Entity of interproximal contact	Precision of interproximal contact between prosthetic crown and adjacent teeth. It was measured by the clinician evaluating the resistance to the sliding of waxed dental floss. The clinician gives to the interproximal contact a score from 0 to 4, where 0 is considered as an absence of resistance (open space between crown and adjacent teeth) and 4 is the total impediment to the floss slide (the crown and the adjacent teeth are too close to have a correct interproximal contact)	2 weeks after definitive prosthesis delivery
Entity of occlusal contact	The entity of contact between prosthetic crown and antagonist teeth was evaluated with a dichromatic articulating paper in order to identify any static and dynamic alterations in occlusal contacts that must be corrected. The clinician gives a score from 0 to 3 where 0 is the absence of contact between crown and antagonists, 1 is a correct contact between them that needs no corrections, 2 there is a slight altered contact that requires minor corrections and 3 there is an altered contact between the prosthetic crown and their antagonists which requires major corrections.	2 weeks after definitive prosthesis delivery
Impression time	Length of time useful to take impression expressed in seconds	2 weeks after definitive prosthesis delivery
Patient satisfaction degree	Patient satisfaction through a VAS scale. The patients is asked to make a mark in an unnumbered line ranging from 0 to 5 where 0 represents maximum comfort and 5 represents a very bad experience. The scale is 5 cm long so the clinician next measures the distance (in cm) from 0 to where the mark was placed by the patient.	2 weeks after definitive prosthesis delivery

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Investigators: Principal Investigator: Massimo Corsalini, Prof., Interdisciplinary Department of Medicine, University of Bari "Aldo Moro"

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UOC Odontostomatologia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The database with study's outcomes will be shared on specific request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No