An interventional study of Laser-sintered removable partial denture and cast removable partial dentures in Partially Edentulous Jaws, sponsored by Faleh Tamimi. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Faleh Tamimi · Not applicable, Interventional, and Treatment
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.
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.
Faleh Tamimi is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
patients received cast removable partial dentures fabricated using traditional lost-wax casting technique.
Other: cast removable partial dentures
patients received removable partial dentures fabricated using laser-sintering.
Device: Laser-sintered removable partial denture
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).
The denture was fabricated traditionally using lost-wax casting technique.
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.
Time frame: after 4 weeks
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.
Time frame: after 2 months
Plan to share: 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.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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