Partially Edentulous JawsNCT02769715
A Study About Patient Satisfaction With Laser-sintered Removable Partial Dentures
A study testing Laser-sintered removable partial denture and cast removable partial dentures in people with Partially Edentulous Jaws, run by Faleh Tamimi at 1 site in Canada.
Trial summary
Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique, a time-consuming and very laborious manual technique. Recently, fabricating removable partial dentures using computer designing and laser sintering techniques have been introduced. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partially Edentulous Jaws
- What is being tested?
- Laser-sintered removable partial denture and cast removable partial dentures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- partially edentulous
- have adequate space for regularly sized prosthetic teeth and metal frame(s)
- be able to maintain adequate oral hygiene and clean their dentures; do not have major systemic health problems that could interfere with general oral health
- have an adequate understanding of written and spoken English or French
- be capable of giving written informed consent and fill out questionnaires
Who cannot join
- there is a lack of minimum interocclusal space to accommodate a metal frame and acrylic material
- they have acute or chronic symptoms of parafunctional disorders
- they have inflammatory mucosal conditions such as lichen planus, progressive periodontitis or others
- they have a history of radiation therapy to the orofacial region
- there are health conditions that may jeopardize the treatment, such as alcoholism,
- they are taking any phenytoin (Dilantin), cortisone or insulin
Show all 9Show fewer
- they have a severe/serious illness that requires frequent hospitalization
- they have impaired cognitive or motor function
- they are unable to return for evaluations/study recalls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser-sintered Removable Partial Dentures: a Crossover Pilot Clinical Trial
Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique, a time-consuming and very laborious manual technique. Recently, fabricating removable partial dentures using computer designing and laser sintering techniques have been introduced. The purpose of this study was to evaluate the patient satisfaction with new computer-generated removable partial dentures and compare it to the traditional removable partial dentures.
Read the detailed description
Patients seeking Removable partial dentures in the undergraduate clinic at McGill University were asked to participate in the study. Patients were treated by undergraduate students under the supervision of expert prosthodontists. Both the dentists treating the case and the patients were blinded to the type of RPD used. The Principal investigator was responsible for preparing the laboratory prescriptions and sending the final impressions to the dental lab in order to assure blinding of the patient and the treating dentists.
Patients were treated according to standardized clinical procedures. Both dentures were fabricated from one master cast to ensure standardization. The cast was scanned digitally to fabricate the laser-sintered dentures, and then was used to fabricate the cast dentures traditionally using lost-wax casting technique. For each patient, two dentures were fabricated from one final impression; one by casting technique and the other by laser-sintering. Patients were given randomly one denture first and followed-up for 1, 2 and 4 weeks. Then, they were given the second denture and followed-up again. At each follow-up visit, patients filled McGill Denture Satisfaction Instrument. At the end of the study patients were asked which denture they prefer to keep.
- Conditions
- Partially Edentulous Jaws
- Being tested
- Laser-sintered removable partial denture, cast removable partial dentures
- Keywords
- Removable partial dentures, partial edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-sintered removable partial dentureDevice
The master cast was scanned using 3D scanner. In the digital file, the path of insertion was determined using a special software. The survey line was drawn and all undesirable undercuts were eliminated. After that, the entire framework design was built virtually 3 dimensionally using a special software (3Shape Software) according to the specified design in three steps: deciding the contour of the component, building the tissue surface then creating the polished surface. The file was saved in STL file and was transferred to rapid prototyping machine. Framework was produced by selective laser sintering technique using the alloy powder (Sintech Metal).
cast removable partial denturesOther
The denture was fabricated traditionally using lost-wax casting technique.
| Study group | Role | What they receive |
|---|---|---|
| cast removable partial denture | Active comparator | patients received cast removable partial dentures fabricated using traditional lost-wax casting technique. Receives: Other: cast removable partial dentures |
| laser-sintered removable partial denture | Experimental | patients received removable partial dentures fabricated using laser-sintering. Receives: Device: Laser-sintered removable partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
Mean patient satisfaction in McGill Denture Satisfaction Survey was assessed in regard to 9 aspects of the dentures; general satisfaction, chewing efficiency, chewing ability, easiness to clean, stability, comfort and oral condition. Mean of patient satisfaction in each of these 9 aspects will be presented for both cast and laser-sintered dentures.
Measured: after 4 weeks
Secondary outcomes (1)
Number of participants who choose to keep the laser-sintered removable partial dentures
Patients will be asked which denture did they prefer to keep after trying both cast and laser-sintered removable partial dentures. The number of patients who preferred each denture will be presented as well as the number of patients who have no preference.
Measured: after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous JawsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faleh Tamimi
- Sponsor type
- University, hospital or other
- Collaborators
- 3DRPD Inc.
- Responsible party
- Sponsor-investigator, Faleh Tamimi, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Faleh Tamimi, Principal investigator, McGill University Faculty of DentistryRubens Albuquerque, Principal investigator, McGill University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769715
- Sponsor's protocol ID
- 12-452 BMD
- Status last verified
- May 2016
- First submitted
- 22 Apr 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The patients' demographic data including (age, sex, the number of missing anterior and posterior teeth, previous denture experience, denture arch, opposing arch and Kennedy classification of the denture, first denture received and preferred denture) will be published in a scientific journal without any indication of personal identity of the patients.
Publications
Koutsoukis T, Zinelis S, Eliades G, Al-Wazzan K, Rifaiy MA, Al Jabbari YS. Selective Laser Melting Technique of Co-Cr Dental Alloys: A Review of Structure and Properties and Comparative Analysis with Other Available Techniques. J Prosthodont. 2015 Jun;24(4):303-12. doi: 10.1111/jopr.12268.
PubMed 26129918Lima JM, Anami LC, Araujo RM, Pavanelli CA. Removable partial dentures: use of rapid prototyping. J Prosthodont. 2014 Oct;23(7):588-91. doi: 10.1111/jopr.12154. Epub 2014 Apr 18.
PubMed 24750472Williams RJ, Bibb R, Eggbeer D, Collis J. Use of CAD/CAM technology to fabricate a removable partial denture framework. J Prosthet Dent. 2006 Aug;96(2):96-9. doi: 10.1016/j.prosdent.2006.05.029.
PubMed 16911885Almufleh B, Emami E, Alageel O, de Melo F, Seng F, Caron E, Nader SA, Al-Hashedi A, Albuquerque R, Feine J, Tamimi F. Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial. J Prosthet Dent. 2018 Apr;119(4):560-567.e1. doi: 10.1016/j.prosdent.2017.04.021. Epub 2017 Jul 11.
PubMed 28709680
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser-sintered Removable Partial Dentures: a Crossover Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT02769715
- Acronym / sponsor ID
- 12-452 BMD
- Conditions
- Partially Edentulous Jaws
- Keywords
- Removable partial dentures, partial edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Faleh TamimiUniversity, hospital or other
- Collaborators
- 3DRPD Inc.
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 May 2016 (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.
Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique, a time-consuming and very laborious manual technique. Recently, fabricating removable partial dentures using computer designing and laser sintering techniques have been introduced. The purpose of this study was to evaluate the patient satisfaction with new computer-generated removable partial dentures and compare it to the traditional removable partial dentures.
Detailed description
Patients seeking Removable partial dentures in the undergraduate clinic at McGill University were asked to participate in the study. Patients were treated by undergraduate students under the supervision of expert prosthodontists. Both the dentists treating the case and the patients were blinded to the type of RPD used. The Principal investigator was responsible for preparing the laboratory prescriptions and sending the final impressions to the dental lab in order to assure blinding of the patient and the treating dentists.
Patients were treated according to standardized clinical procedures. Both dentures were fabricated from one master cast to ensure standardization. The cast was scanned digitally to fabricate the laser-sintered dentures, and then was used to fabricate the cast dentures traditionally using lost-wax casting technique. For each patient, two dentures were fabricated from one final impression; one by casting technique and the other by laser-sintering. Patients were given randomly one denture first and followed-up for 1, 2 and 4 weeks. Then, they were given the second denture and followed-up again. At each follow-up visit, patients filled McGill Denture Satisfaction Instrument. At the end of the study patients were asked which denture they prefer to keep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cast removable partial denture | Active comparator | Other: cast removable partial denturespatients received cast removable partial dentures fabricated using traditional lost-wax casting technique. |
| laser-sintered removable partial denture | Experimental | Device: Laser-sintered removable partial denturepatients received removable partial dentures fabricated using laser-sintering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- partially edentulous
- have adequate space for regularly sized prosthetic teeth and metal frame(s)
- be able to maintain adequate oral hygiene and clean their dentures; do not have major systemic health problems that could interfere with general oral health
- have an adequate understanding of written and spoken English or French
- be capable of giving written informed consent and fill out questionnaires
Key exclusion criteria (9 listed)
- there is a lack of minimum interocclusal space to accommodate a metal frame and acrylic material
- they have acute or chronic symptoms of parafunctional disorders
- they have inflammatory mucosal conditions such as lichen planus, progressive periodontitis or others
- they have a history of radiation therapy to the orofacial region
- there are health conditions that may jeopardize the treatment, such as alcoholism,
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 |
|---|---|---|
| Laser-sintered removable partial dentureThe master cast was scanned using 3D scanner. In the digital file, the path of insertion was determined using a special software. The survey line was drawn and all undesirable undercuts were eliminated. After that, the entire framework design was built virtually 3 dimensionally using a special software (3Shape Software) according to the specified design in three steps: deciding the contour of the component, building the tissue surface then creating the polished surface. The file was saved in STL file and was transferred to rapid prototyping machine. Framework was produced by selective laser sintering technique using the alloy powder (Sintech Metal). | Device | laser-sintered removable partial denture |
| cast removable partial denturesThe denture was fabricated traditionally using lost-wax casting technique. | Other | cast removable partial denture |
Primary outcome
Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
Time frame: after 4 weeks
Mean patient satisfaction in McGill Denture Satisfaction Survey was assessed in regard to 9 aspects of the dentures; general satisfaction, chewing efficiency, chewing ability, easiness to clean, stability, comfort and oral condition. Mean of patient satisfaction in each of these 9 aspects will be presented for both cast and laser-sintered dentures.
1 secondary outcome
Number of participants who choose to keep the laser-sintered removable partial dentures
Time frame: after 2 months
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 12 May 2016.
- Background: PubMed 26129918Koutsoukis T, Zinelis S, Eliades G, Al-Wazzan K, Rifaiy MA, Al Jabbari YS. Selective Laser Melting Technique of Co-Cr Dental Alloys: A Review of Structure and Properties and Comparative Analysis with Other Available Techniques. J Prosthodont. 2015 Jun;24(4):303-12. doi: 10.1111/jopr.12268.
- Background: PubMed 24750472Lima JM, Anami LC, Araujo RM, Pavanelli CA. Removable partial dentures: use of rapid prototyping. J Prosthodont. 2014 Oct;23(7):588-91. doi: 10.1111/jopr.12154. Epub 2014 Apr 18.
- Background: PubMed 16911885Williams RJ, Bibb R, Eggbeer D, Collis J. Use of CAD/CAM technology to fabricate a removable partial denture framework. J Prosthet Dent. 2006 Aug;96(2):96-9. doi: 10.1016/j.prosdent.2006.05.029.
- Derived from this study: PubMed 28709680Almufleh B, Emami E, Alageel O, de Melo F, Seng F, Caron E, Nader SA, Al-Hashedi A, Albuquerque R, Feine J, Tamimi F. Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial. J Prosthet Dent. 2018 Apr;119(4):560-567.e1. doi: 10.1016/j.prosdent.2017.04.021. Epub 2017 Jul 11.
- Individual participant dataSharing planned: Yes. The patients' demographic data including (age, sex, the number of missing anterior and posterior teeth, previous denture experience, denture arch, opposing arch and Kennedy classification of the denture, first denture received and preferred denture) will be published in a scientific journal without any indication of personal identity of the patients.
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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.
Faleh Tamimi principal investigator
McGill University Faculty of Dentistry
Rubens Albuquerque principal investigator
McGill University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-sintered removable partial denture and cast removable partial dentures in people with Partially Edentulous Jaws, run by Faleh Tamimi at 1 site in Canada.
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 5 inclusion and 9 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 12 May 2016. 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 Canada. 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?
Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100 (time frame: after 4 weeks). 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 NCT02769715, which also lists 4 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 12 May 2016.