Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05585008
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-10-12
Brief Title:
Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture An In-Vivo Comparative Study
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction
One major complaint frequently voiced by complete denture wearers is denture retention Conventional denture disadvantage is heat-curing resin deformation In addition the pack and press technique that is still more common residual stresses that occur at the time of packing are released when the material is removed from the flask causing the resin to shrink and this shrinkage is cited as a cause of poor fit of the denture base In the field of prosthetic dentistry the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality the mechanical properties of printed parts the total cost and the manufacturing time The milling process wastes large quantities of denture base material and more recent three-dimensional 3D prototyping promises a more sustainable additive approach by using less denture resin However no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing
Aim of the study
Investigate the effect of two techniques of complete denture manufacturing conventional and 3D printed on denture retention trueness accuracy and satisfaction
Methodology
Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups group A for conventional dentures and group B for 3D printed dentures retention for the two groups will be measured at 01 and 3 months and patient satisfaction will be recorded and accuracy of the denture base will be measured on the software The results will be tabulated and statistically analyzed using the SPSS program
One major complaint frequently voiced by complete denture wearers is denture retention Conventional denture disadvantage is heat-curing resin deformation In addition the pack and press technique that is still more common residual stresses that occur at the time of packing are released when the material is removed from the flask causing the resin to shrink and this shrinkage is cited as a cause of poor fit of the denture base In the field of prosthetic dentistry the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality the mechanical properties of printed parts the total cost and the manufacturing time The milling process wastes large quantities of denture base material and more recent three-dimensional 3D prototyping promises a more sustainable additive approach by using less denture resin However no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing
Aim of the study
Investigate the effect of two techniques of complete denture manufacturing conventional and 3D printed on denture retention trueness accuracy and satisfaction
Methodology
Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups group A for conventional dentures and group B for 3D printed dentures retention for the two groups will be measured at 01 and 3 months and patient satisfaction will be recorded and accuracy of the denture base will be measured on the software The results will be tabulated and statistically analyzed using the SPSS program
Detailed Description:
Twenty patients will be selected from the Faculty of Dentistry Suez Canal University outpatient clinics with the following criteria
Patients with good neuromuscular control and free of systemic diseases
Well-formed ridges with firm and healthy mucosa and no bilateral anterior undercuts
The patients will be divided equally into two groupsn10 group A which will receive conventional heat cure acrylic denture and group B which will receive 3D printed denture
Methodology
A primary impression will be taken for each patient and a special self-cured acrylic tray will be fabricated
Zinc oxide secondary impression caves outline Cavex Hollandwill be taken for each patient The impression will be poured with extra hard stone and labeled master cast
The cast will be scanned and saved in standard tessellation language stl format master cats
Jaw relation records for each patient will be taken in the conventional method For group A the setting up of teeth will be done in a conventional way on the articulator and flasking of the waxed-up denture will be done Wax elimination will be done then packing of heat cure acrylic will be done
For group B occlusion block will be scanned swing scanner DOF inc Koreathe scanner has an accuracy of 10 μm after taking jaw relation record
Virtual teeth form size and setting will be done on the CAD software Exocad Dental CAD 30 Exocad GmbH Germany according to jaw relation record
The denture base extension and thickness will be designed on CAD software The teeth will be exported in a separate file and the denture base will be exported in a separate stl file
The virtual denture stl files will be sent to the 3D printer software Chitubox software CBD-Tech china where slicing of the file and adjustment of layers setting will be done
The virtual denture will be sent to the 3D printer photon 3d printer ANYCUBIC 3D Printing china to be printed printer has Y axis resolution 125um and Layer resolution 25 100um Teeth will be printed alone using tooth-colored resindental sand Harz labs Russia and base will be printed alone using pink resindental pink HArzz lab Russia then it will be ethyl alcohol washed 99 ethyl alcohol to remove excess resin The teeth will be placed in their places in the denture base and secured using pink resin
Post-curing for remaining uncured resin will be done using a post-curing chamber for 30 minutes bre-lux power unit 2bredent united kingdom
Regarding the maxillary denture
Retention will be measured clinically by using a force gauge weihang electronic gaugeweihang industries china for group A and group B at 01 and 3 months A force gauge will be applied by fixing the chain at the center of the polished surface of the denture The pull end of the force gauge will be connected to the denture to measure the retention The force gauge will pull the denture vertically downward until denture retention will be lost and the denture will move vertically The force at which the denture dislodges will be recorded in grams The pull-off procedure will be repeated 10 times to obtain 10 records for each elder and then the mean of these records will be calculated
Participants will answer a denture satisfaction questionnaire Possible answers for each question and respective scores will be unsatisfactory 0 regular 1 and good 2 Rehmann et al 2008 For group A and group B denture base will be checked for accuracy of fit after scanning using a bench scanner with 13 megapixels dual camera and 10-micron accuracy swing scanner DOF inc Korea and will be compared to the virtual one planned on the master cast using metrology software Geomagic Control X3D systems Canada This will be done by the superimposition of the scanned printed or processed denture and the virtual reference denture This will be done by selecting a point-to-point match and then the best fit function
Color maps of the surface matching differences will be done Areas that will be yellow to red in color will indicate impingement of the denture base with the cast Areas that will be blue in color will indicate space between the denture base and cast The ideal denture will show a color map that will be entirely green giving a measurement value of 0 which will represent no processing deformation and an ideal adaptation of the denture base to the cast
The results will be tabulated and statistically analyzed using SPSS Statistics Version 20 for Windows SPSS Inc an IBM Company USA
Patients with good neuromuscular control and free of systemic diseases
Well-formed ridges with firm and healthy mucosa and no bilateral anterior undercuts
The patients will be divided equally into two groupsn10 group A which will receive conventional heat cure acrylic denture and group B which will receive 3D printed denture
Methodology
A primary impression will be taken for each patient and a special self-cured acrylic tray will be fabricated
Zinc oxide secondary impression caves outline Cavex Hollandwill be taken for each patient The impression will be poured with extra hard stone and labeled master cast
The cast will be scanned and saved in standard tessellation language stl format master cats
Jaw relation records for each patient will be taken in the conventional method For group A the setting up of teeth will be done in a conventional way on the articulator and flasking of the waxed-up denture will be done Wax elimination will be done then packing of heat cure acrylic will be done
For group B occlusion block will be scanned swing scanner DOF inc Koreathe scanner has an accuracy of 10 μm after taking jaw relation record
Virtual teeth form size and setting will be done on the CAD software Exocad Dental CAD 30 Exocad GmbH Germany according to jaw relation record
The denture base extension and thickness will be designed on CAD software The teeth will be exported in a separate file and the denture base will be exported in a separate stl file
The virtual denture stl files will be sent to the 3D printer software Chitubox software CBD-Tech china where slicing of the file and adjustment of layers setting will be done
The virtual denture will be sent to the 3D printer photon 3d printer ANYCUBIC 3D Printing china to be printed printer has Y axis resolution 125um and Layer resolution 25 100um Teeth will be printed alone using tooth-colored resindental sand Harz labs Russia and base will be printed alone using pink resindental pink HArzz lab Russia then it will be ethyl alcohol washed 99 ethyl alcohol to remove excess resin The teeth will be placed in their places in the denture base and secured using pink resin
Post-curing for remaining uncured resin will be done using a post-curing chamber for 30 minutes bre-lux power unit 2bredent united kingdom
Regarding the maxillary denture
Retention will be measured clinically by using a force gauge weihang electronic gaugeweihang industries china for group A and group B at 01 and 3 months A force gauge will be applied by fixing the chain at the center of the polished surface of the denture The pull end of the force gauge will be connected to the denture to measure the retention The force gauge will pull the denture vertically downward until denture retention will be lost and the denture will move vertically The force at which the denture dislodges will be recorded in grams The pull-off procedure will be repeated 10 times to obtain 10 records for each elder and then the mean of these records will be calculated
Participants will answer a denture satisfaction questionnaire Possible answers for each question and respective scores will be unsatisfactory 0 regular 1 and good 2 Rehmann et al 2008 For group A and group B denture base will be checked for accuracy of fit after scanning using a bench scanner with 13 megapixels dual camera and 10-micron accuracy swing scanner DOF inc Korea and will be compared to the virtual one planned on the master cast using metrology software Geomagic Control X3D systems Canada This will be done by the superimposition of the scanned printed or processed denture and the virtual reference denture This will be done by selecting a point-to-point match and then the best fit function
Color maps of the surface matching differences will be done Areas that will be yellow to red in color will indicate impingement of the denture base with the cast Areas that will be blue in color will indicate space between the denture base and cast The ideal denture will show a color map that will be entirely green giving a measurement value of 0 which will represent no processing deformation and an ideal adaptation of the denture base to the cast
The results will be tabulated and statistically analyzed using SPSS Statistics Version 20 for Windows SPSS Inc an IBM Company USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None