Partially Edentulous PatientsNCT01191073
Manually Versus Digitally Fabricated Removable Partial Dentures
A study testing CAD/CAM fabricated RPD's and traditional fabricated RPD's in people with Partially Edentulous Patients, run by University Ghent at 1 site in Belgium.
Trial summary
In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Patients
- What is being tested?
- CAD/CAM fabricated RPD's and traditional fabricated RPD's
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in need of a classic removable partial denture (RPD)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures
In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.
During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.
Read the detailed description
The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.
Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.
In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.
In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.
Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.
During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.
Hypothesis1: CAD/CAM fabricated RPD's can meet the clinical standards for RPD's.
Hypothesis 2: Dentists do not observe a difference between the classic and CAD/CAM fabricated RPD.
Hypothesis 3: Patients do not see/feel any difference between the classic and CAD/CAM fabricated RPD.
- Conditions
- Partially Edentulous Patients
- Being tested
- CAD/CAM fabricated RPD's, traditional fabricated RPD's
- Keywords
- edentulous
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM fabricated RPD'sDevice
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
traditional fabricated RPD'sDevice
group receiving traditional fabricated dentures (double blind)
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM fabricated dentures | Experimental | group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind) Receives: Device: CAD/CAM fabricated RPD's |
| traditional fabricated dentures | Active comparator | group receiving traditional fabricated dentures (double blind) Receives: Device: traditional fabricated RPD's |
What is being measured
The primary outcome is the main question the study is designed to answer.
fit of framework
After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.
Measured: 9 months
Secondary outcomes (2)
placement of RPD + control of placement
There will be a placement of a removable partial denture, and after 3 to 5 days, this placement will be re-checked as a follow up.
Measured: 3 to 5 days
re-evaluation of the RPD placement
Every 6 months, for 5 years, the RPD placement will be followed up.
Measured: every 6 months, for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous PatientsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieve Van Zeghbroeck, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191073
- Sponsor's protocol ID
- 2009/655
- Status last verified
- Nov 2021
- First submitted
- 26 Aug 2010
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures
- ClinicalTrials.gov ID
- NCT01191073
- Acronym / sponsor ID
- 2009/655
- Conditions
- Partially Edentulous Patients
- Keywords
- edentulous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Aug 2010 (estimated)
- 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.
In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.
During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.
Detailed description
The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.
Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.
In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.
In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.
Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.
During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.
Hypothesis1: CAD/CAM fabricated RPD's can meet the clinical standards for RPD's.
Hypothesis 2: Dentists do not observe a difference between the classic and CAD/CAM fabricated RPD.
Hypothesis 3: Patients do not see/feel any difference between the classic and CAD/CAM fabricated RPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM fabricated dentures | Experimental | Device: CAD/CAM fabricated RPD'sgroup receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind) |
| traditional fabricated dentures | Active comparator | Device: traditional fabricated RPD'sgroup receiving traditional fabricated dentures (double blind) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients in need of a classic removable partial denture (RPD)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CAD/CAM fabricated RPD'sgroup receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind) | Device | CAD/CAM fabricated dentures |
| traditional fabricated RPD'sgroup receiving traditional fabricated dentures (double blind) | Device | traditional fabricated dentures |
Primary outcome
fit of framework
Time frame: 9 months
After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.
2 secondary outcomes
placement of RPD + control of placement
Time frame: 3 to 5 days
re-evaluation of the RPD placement
Time frame: every 6 months, for 5 years
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 1 Dec 2021.
Related trials for Partially Edentulous Patients
Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Not yet recruiting
Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study
Partially Edentulous Mandible
Active, not recruitingObservational study
Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
Edentulism, Edentulism Complete
Recruiting
Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Partially Edentulous Jaw, Tooth Loss
Active, not recruiting
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
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.
Lieve Van Zeghbroeck, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM fabricated RPD's and traditional fabricated RPD's in people with Partially Edentulous Patients, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 0 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 1 Dec 2021. 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 Belgium. 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?
fit of framework (time frame: 9 months). 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 1 Dec 2021.