Clinical trial NCT02769715: A Study About Patient Satisfaction With Laser-sintered Removable Partial Dentures
Official title: Laser-sintered Removable Partial Dentures: a Crossover Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partially Edentulous Jaws
Keywords: Removable partial dentures
partial edentulism
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: 3DRPD Inc.
First posted: 2016-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
timeFrame: after 4 weeks
Secondary outcomes:
measure: Number of participants who choose to keep the laser-sintered removable partial dentures
timeFrame: after 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Faculty of Dentistry
state: Quebec
Study officials:
affiliation: McGill University Faculty of Dentistry
name: Faleh Tamimi
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Faculty of Dentistry
name: Rubens Albuquerque
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lima 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.
citation: Williams 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.
citation: Almufleh 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.