Clinical trial NCT06215781: Comparison Between Conventional and Digital Workflow in Dental Prosthesis
Official title: Comparison Between Conventional and Digital Workflow in Fixed Dental Prosthetic Rehabilitations: a Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Prosthesis Complication
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arms groups
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Entity of interproximal contact
timeFrame: 2 weeks after definitive prosthesis delivery
measure: Entity of occlusal contact
timeFrame: 2 weeks after definitive prosthesis delivery
measure: Impression time
timeFrame: 2 weeks after definitive prosthesis delivery
measure: Patient satisfaction degree
timeFrame: 2 weeks after definitive prosthesis delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Massimo Corsalini
Study officials:
affiliation: Interdisciplinary Department of Medicine, University of Bari "Aldo Moro"
name: Massimo Corsalini, Prof.
role: PRINCIPAL_INVESTIGATOR
References: