Dental Prosthesis ComplicationNCT06215781
Comparison Between Conventional and Digital Workflow in Dental Prosthesis
A study testing Fully digital workflow of prosthetic fixed dental crown, Combined digital and conventional workflows of prosthetic fixed dental crown and Fully conventional workflow of prosthetic fixed dental crown in people with Dental Prosthesis Complication, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis Complication
- What is being tested?
- Fully digital workflow of prosthetic fixed dental crown, Combined digital and conventional workflows of prosthetic fixed dental crown and Fully conventional workflow of prosthetic fixed dental crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2018to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good oral health
- good general health conditions
- no contraindication to oral surgery and fixed prosthesis
- patients who completed the 6 months follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Prosthesis Complication
- Being tested
- Fully digital workflow of prosthetic fixed dental crown, Combined digital and conventional workflows of prosthetic fixed dental crown, Fully conventional workflow of prosthetic fixed dental crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully digital workflow of prosthetic fixed dental crownProcedure or surgery
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 and conventional workflows of prosthetic fixed dental crownProcedure or surgery
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 of prosthetic fixed dental crownProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: 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. Receives: Procedure: Fully conventional workflow of prosthetic fixed dental crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 2 weeks after definitive prosthesis delivery
Impression time
Length of time useful to take impression expressed in seconds
Measured: 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.
Measured: 2 weeks after definitive prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start7 Jan 2018
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arms groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Corsalini, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Investigators
- Massimo Corsalini, Prof., Principal investigator, Interdisciplinary Department of Medicine, University of Bari "Aldo Moro"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215781
- Sponsor's protocol ID
- UOC Odontostomatologia
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database with study's outcomes will be shared on specific request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional and Digital Workflow in Fixed Dental Prosthetic Rehabilitations: a Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06215781
- Acronym / sponsor ID
- UOC Odontostomatologia
- Conditions
- Dental Prosthesis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arms groups
| Arm | Type | Receives |
|---|---|---|
| Fully digital workflow | Experimental | Procedure: Fully digital workflow of prosthetic fixed dental crownPatients of this group are subjected to entire digital workflow, from the digital planning to the delivery of definitive zirconia fixed dental prosthesis |
| Combined digital-conventional workflows | Experimental | Procedure: Combined digital and conventional workflows of prosthetic fixed dental crownPatients of this group were subjected to every digital steps as the "fully digital workflow" arm, except for the impression that includes analog material (silicones). |
| Fully conventional workflow | Active comparator | Procedure: Fully conventional workflow of prosthetic fixed dental crownPatients of this group follow the entire analog protocol. All the procedures exclude digital involvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- good oral health
- good general health conditions
- no contraindication to oral surgery and fixed prosthesis
- patients who completed the 6 months follow-up
Key exclusion criteria (6 listed)
- bad oral health
- bad general health conditions (with multi-drug therapy)
- periodontitis or dental caries susceptibly
- parafunctions presence
- TMJ disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully digital workflow of prosthetic fixed dental crownThe 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. | Procedure or surgery | Fully digital workflow |
| Combined digital and conventional workflows of prosthetic fixed dental crownThe 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. | Procedure or surgery | Combined digital-conventional workflows |
| Fully conventional workflow of prosthetic fixed dental crownThe 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. | Procedure or surgery | Fully conventional workflow |
Primary outcome
Entity of interproximal contact
Time frame: 2 weeks after definitive prosthesis delivery
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)
Entity of occlusal contact
Time frame: 2 weeks after definitive prosthesis delivery
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.
Impression time
Time frame: 2 weeks after definitive prosthesis delivery
Length of time useful to take impression expressed in seconds
Patient satisfaction degree
Time frame: 2 weeks after definitive prosthesis delivery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No. The database with study's outcomes will be shared on specific request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Corsalini, Prof. principal investigator
Interdisciplinary Department of Medicine, University of Bari "Aldo Moro"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully digital workflow of prosthetic fixed dental crown, Combined digital and conventional workflows of prosthetic fixed dental crown and Fully conventional workflow of prosthetic fixed dental crown in people with Dental Prosthesis Complication, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entity of interproximal contact (time frame: 2 weeks after definitive prosthesis delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.