Jaw, Edentulous, PartiallyFlexNCT01816425
Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures
A study testing Thermoplastic partial denture and CoCr partial denture in people with Jaw, Edentulous, Partially, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Thermoplastic partial denture and CoCr partial denture
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Jul 2014
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old or older patient with partial edentulous jaws with indication of removable partial denture
Who cannot join
- patient younger than 60 years patient with edentulous mouth
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dentistry College, University of São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures: Random Clinical Trial
The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and stability. To get the proper planning, we need to assess the dental support system, with its qualitative and quantitative values. But conventional dentures has a inherent problem which is the metallic elements apparent and in some cases the stiffness of the component support elements that generates stress.
The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in oral rehabilitation. So many treatments are being done in everyday practice without a defined concept on various aspects of its construction and oral applicability.
Read more
This trial aims to assess the basic parameters of both dentures in: nutrition, speech therapy, chewing force, chewing efficiency and quality of life.
60 years old or older patients who require removable prosthesis. These will be randomly selected for the fabrication and installation of removable partial dentures (Gold Standard - control group - CoCr partial denture) and thermoplastic partial denture(experimental group).
Before beginning the work, selected patients will make some preliminary tests such as controlling the individual condition, they are:
- three questionnaires:
- instrument for assessing quality of life related to oral health, GOHAI - General Oral Health Assessment Index of Atchinson \& Dolan
- instrument for assessing the social and economic profile of ABEP (Brazilian Association of Research Companies) CCEB 2011;
- Instrument for assessing cognitive condition MINI-MENTAL;
- Speech evaluation
- Nutritional assessment;
- Evaluation of masticatory efficiency and
- Chewing strength. After preliminary assessments patients will be subjected to treatments for manufacture of partial dentures. After the installation (end of the technical construction of the dentures) and the adjustments appointment the tests will be repeated and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24 months respectively, when the tests will do again now to see if there was a change in the initial condition.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Thermoplastic partial denture, CoCr partial denture
- Keywords
- Dental Prosthesis, Dental Prosthesis Design
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoplastic partial dentureDevice
CoCr partial dentureDevice
| Study group | Role | What they receive |
|---|---|---|
| thermoplastic partial denture | Experimental | The patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment Receives: Device: Thermoplastic partial denture |
| CoCr partial denture | Active comparator | The patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment Receives: Device: CoCr partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between thermoplastic partial denture and CoCr partial dentures
the tests result of the thermoplastic partial denture will be compared with the tests result of the CoCr partial dentures, the hypothesis is that thermoplastic partial denture are similar to CoCr partial dentures
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionNov 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Érico Castaldin Fraga Moreira, University of Sao Paulo
- Investigators
- Roberto C Stegun, Phd, Principal investigator, Dentistry College, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816425
- Sponsor's protocol ID
- Thermoplastic Denture Base
- Acronym
- Flex
- Status last verified
- Mar 2013
- First submitted
- 20 Feb 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
VandenBrink JP, Wolfaardt JF, Faulkner MG. A comparison of various removable partial denture clasp materials and fabrication procedure for placing clasps on canine and premolar teeth. J Prosthet Dent. 1993 Aug;70(2):180-8. doi: 10.1016/0022-3913(93)90016-h.
PubMed 8103801Wu JC, Latta GH Jr, Wicks RA, Swords RL, Scarbecz M. In vitro deformation of acetyl resin and metal alloy removable partial denture direct retainers. J Prosthet Dent. 2003 Dec;90(6):586-90. doi: 10.1016/j.prosdent.2003.09.020.
PubMed 14668760
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures: Random Clinical Trial
- ClinicalTrials.gov ID
- NCT01816425
- Acronym / sponsor ID
- Flex / Thermoplastic Denture Base
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Dental Prosthesis, Dental Prosthesis Design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Mar 2013 (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.
The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and stability. To get the proper planning, we need to assess the dental support system, with its qualitative and quantitative values. But conventional dentures has a inherent problem which is the metallic elements apparent and in some cases the stiffness of the component support elements that generates stress.
The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in oral rehabilitation. So many treatments are being done in everyday practice without a defined concept on various aspects of its construction and oral applicability.
This trial aims to assess the basic parameters of both dentures in: nutrition, speech therapy, chewing force, chewing efficiency and quality of life.
60 years old or older patients who require removable prosthesis. These will be randomly selected for the fabrication and installation of removable partial dentures (Gold Standard - control group - CoCr partial denture) and thermoplastic partial denture(experimental group).
Before beginning the work, selected patients will make some preliminary tests such as controlling the individual condition, they are:
- three questionnaires:
- instrument for assessing quality of life related to oral health, GOHAI - General Oral Health Assessment Index of Atchinson \& Dolan
- instrument for assessing the social and economic profile of ABEP (Brazilian Association of Research Companies) CCEB 2011;
- Instrument for assessing cognitive condition MINI-MENTAL;
- Speech evaluation
- Nutritional assessment;
- Evaluation of masticatory efficiency and
- Chewing strength. After preliminary assessments patients will be subjected to treatments for manufacture of partial dentures. After the installation (end of the technical construction of the dentures) and the adjustments appointment the tests will be repeated and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24 months respectively, when the tests will do again now to see if there was a change in the initial condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thermoplastic partial denture | Experimental | Device: Thermoplastic partial dentureThe patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment |
| CoCr partial denture | Active comparator | Device: CoCr partial dentureThe patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years old or older patient with partial edentulous jaws with indication of removable partial denture
Key exclusion criteria (1 listed)
- patient younger than 60 years patient with edentulous mouth
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 |
|---|---|---|
| Thermoplastic partial denture | Device | thermoplastic partial denture |
| CoCr partial denture | Device | CoCr partial denture |
Primary outcome
Comparison between thermoplastic partial denture and CoCr partial dentures
Time frame: 24 months
the tests result of the thermoplastic partial denture will be compared with the tests result of the CoCr partial dentures, the hypothesis is that thermoplastic partial denture are similar to CoCr partial dentures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Background: PubMed 8103801VandenBrink JP, Wolfaardt JF, Faulkner MG. A comparison of various removable partial denture clasp materials and fabrication procedure for placing clasps on canine and premolar teeth. J Prosthet Dent. 1993 Aug;70(2):180-8. doi: 10.1016/0022-3913(93)90016-h.
- Background: PubMed 14668760Wu JC, Latta GH Jr, Wicks RA, Swords RL, Scarbecz M. In vitro deformation of acetyl resin and metal alloy removable partial denture direct retainers. J Prosthet Dent. 2003 Dec;90(6):586-90. doi: 10.1016/j.prosdent.2003.09.020.
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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.
Roberto C Stegun, Phd principal investigator
Dentistry College, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoplastic partial denture and CoCr partial denture in people with Jaw, Edentulous, Partially, run by University of Sao Paulo at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2013. 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 Brazil. 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?
Results are not available in the source record.
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?
Comparison between thermoplastic partial denture and CoCr partial dentures (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816425, which also lists 2 linked publications.
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 25 Mar 2013.