A Study About Patient Satisfaction With Laser-sintered Removable Partial Dentures

NCT02769715 | Completed DMC

• 1 other identifier: 12-452 BMD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Partially Edentulous Jaws

Keywords

Removable partial dentures; partial edentulism

Outcome Measures

Primary Outcomes (1)

• 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.

  after 4 weeks

Secondary Outcomes (1)

• Number of participants who choose to keep the laser-sintered removable partial dentures

  after 2 months

Study Arms (2)

cast removable partial denture

ACTIVE COMPARATOR

patients received cast removable partial dentures fabricated using traditional lost-wax casting technique.

Other: cast removable partial dentures

laser-sintered removable partial denture

EXPERIMENTAL

patients received removable partial dentures fabricated using laser-sintering.

Device: Laser-sintered removable partial denture

Interventions

Laser-sintered removable partial denture DEVICE

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).

laser-sintered removable partial denture

cast removable partial dentures OTHER

The denture was fabricated traditionally using lost-wax casting technique.

cast removable partial denture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faleh Tamimi: lead
• 3DRPD Inc.: collaborator

Study Sites (1)

McGill University Faculty of Dentistry

Montreal, Quebec, H3A 1G1, Canada

Location

Related Publications (4)

• 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.

  PMID: 26129918 BACKGROUND

• 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.

  PMID: 24750472 BACKGROUND

• 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.

  PMID: 16911885 BACKGROUND

• 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.

  PMID: 28709680 DERIVED

Study Officials

• Faleh Tamimi

  McGill University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Rubens Albuquerque

  McGill University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor and Canada Research Chair in Translational Craniofacial Research

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 12, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)