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

Primary Purpose

Partially Edentulous Jaws

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Laser-sintered removable partial denture
cast removable partial dentures
Sponsored by
Faleh Tamimi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Jaws focused on measuring Removable partial dentures, partial edentulism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • McGill University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

cast removable partial denture

laser-sintered removable partial denture

Arm Description

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

patients received removable partial dentures fabricated using laser-sintering.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 22, 2016
Last Updated
May 10, 2016
Sponsor
Faleh Tamimi
Collaborators
3DRPD Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02769715
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faleh Tamimi
Collaborators
3DRPD Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Jaws
Keywords
Removable partial dentures, partial edentulism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cast removable partial denture
Arm Type
Active Comparator
Arm Description
patients received cast removable partial dentures fabricated using traditional lost-wax casting technique.
Arm Title
laser-sintered removable partial denture
Arm Type
Experimental
Arm Description
patients received removable partial dentures fabricated using laser-sintering.
Intervention Type
Device
Intervention Name(s)
Laser-sintered removable partial denture
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
cast removable partial dentures
Intervention Description
The denture was fabricated traditionally using lost-wax casting technique.
Primary Outcome Measure Information:
Title
Mean of patient satisfaction measured by McGill Denture Satisfaction Survey using visual analog scale from 0-100
Description
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
Secondary Outcome Measure Information:
Title
Number of participants who choose to keep the laser-sintered removable partial dentures
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faleh Tamimi
Organizational Affiliation
McGill University Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rubens Albuquerque
Organizational Affiliation
McGill University Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Faculty of Dentistry
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
26129918
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.
Results Reference
background
PubMed Identifier
24750472
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.
Results Reference
background
PubMed Identifier
16911885
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.
Results Reference
background
PubMed Identifier
28709680
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.
Results Reference
derived

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

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