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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:
The null hypothesis is that are no differences between the three groups for each parameter.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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). |
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| Fully conventional workflow | Active Comparator | Patients of this group follow the entire analog protocol. All the procedures exclude digital involvement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Corsalini, Prof. | Interdisciplinary Department of Medicine, University of Bari "Aldo Moro" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massimo Corsalini | Bari | 70124 | Italy |
The database with study's outcomes will be shared on specific request.
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Three-arms groups
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| 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. |
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| 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. |
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