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

F

Faleh Tamimi

Status

Completed

Conditions

Partially Edentulous Jaws

Treatments

Device: Laser-sintered removable partial denture
Other: cast removable partial dentures

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02769715
12-452 BMD

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups

cast removable partial denture
Active Comparator group
Description:
patients received cast removable partial dentures fabricated using traditional lost-wax casting technique.
Treatment:
Other: cast removable partial dentures
laser-sintered removable partial denture
Experimental group
Description:
patients received removable partial dentures fabricated using laser-sintering.
Treatment:
Device: Laser-sintered removable partial denture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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