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Completed

NCT Number: NCT02769715

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Faculty of Dentistry

Montreal, Quebec, H3A 1G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

cast removable partial dentures

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: after 2 months

    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.

Sponsors and collaborators

Lead sponsor

Faleh Tamimi

Other

Collaborators

  • 3DRPD Inc.

Registry information

Official study title

Laser-sintered Removable Partial Dentures: a Crossover Pilot Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 12, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.