Comparison Between Conventional and Digital Workflow in Dental Prosthesis

NCT06215781 | Completed

• 1 other identifier: UOC Odontostomatologia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Prosthesis Complication

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Fully digital workflow

EXPERIMENTAL

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

Combined digital-conventional workflows

EXPERIMENTAL

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

Fully conventional workflow

ACTIVE COMPARATOR

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

Procedure: Fully conventional workflow of prosthetic fixed dental crown

Interventions

Fully digital workflow of prosthetic fixed dental crown 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.

Fully digital workflow

Combined digital and conventional workflows of prosthetic fixed dental crown 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.

Combined digital-conventional workflows

Fully conventional workflow of prosthetic fixed dental crown 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.

Fully conventional workflow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Massimo Corsalini

Bari, 70124, Italy

Location

Study Officials

• Massimo Corsalini, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Three-arms groups

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 22, 2024
• Study Start: January 7, 2018
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)