Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103019
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-10-22
Brief Title:
Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures
Sponsor:
Fatma mahanna
Organization:
Mansoura University
Study Overview
Official Title:
Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures A Randomized Crossover Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Twenty completely edentulous patients were enrolled in this study Each patient received two types of prostheses 1 Conventional complete dentures 2 3D printed dimethacrylate-based resin complete dentures Patient satisfaction was assessed using the oral health impact profile OHIP-EDENT-N survey questionnaire and masticatory performance was evaluated with the two-colored chewing gum mixing ability by evaluation of the standard deviation of hue at T0 at the time of complete denture insertion T3 after 3 months of denture use and T6 after 6 months of denture use
Detailed Description:
For each patient conventional maxillary and mandibular complete dentures were constructed followed by 3D printed complete dentures construction as follows Scanning of maxillary and mandibular complete dentures and scanning of master casts were done using 3D scanner VDSL Home Gateway model EchoLife DG8045 China after lightly coated with anti-glare spray Siladent Marmoscan spray basic Ref 250022 The resultant data in STL format were transmitted to the CAD-CAM complete denture provider using a purpose-built software program Exocad DentalIDB 24 plovdiv7290version 24 Enginebuld 7290 The anatomic landmarks were identified and the peripheral limits were marked on a virtual model in the design software which then were served to design the definitive complete denture
The scanned STL image of the conventional complete denture which have been previously constructed was superimposed on the newly designed denture for comparison of polished surface teeth alignment size and form of teeth A digital preview was generated and sent for approval before fabrication
Printing Preparation The denture base shade was selected and then the cassette of the 3D printer RASDENT 3D printer was filled with fresh DENTCA Denture Base II dimethacrylate-based resins with photo-initiator Then the printer door closed Printing procedures The denture base model STL file was uploaded into the software The denture base was oriented vertically on the build platform Supports were generated around the perimeter of the denture base The desired slice thickness was selected and then the printing was started Cleaning Bonding teeth to the denture base Post-curing procedures Finishing Evaluation of patient satisfaction The OHRQoL of the patient was assessed using an instrument called OHIP-EDENT-N10
The scanned STL image of the conventional complete denture which have been previously constructed was superimposed on the newly designed denture for comparison of polished surface teeth alignment size and form of teeth A digital preview was generated and sent for approval before fabrication
Printing Preparation The denture base shade was selected and then the cassette of the 3D printer RASDENT 3D printer was filled with fresh DENTCA Denture Base II dimethacrylate-based resins with photo-initiator Then the printer door closed Printing procedures The denture base model STL file was uploaded into the software The denture base was oriented vertically on the build platform Supports were generated around the perimeter of the denture base The desired slice thickness was selected and then the printing was started Cleaning Bonding teeth to the denture base Post-curing procedures Finishing Evaluation of patient satisfaction The OHRQoL of the patient was assessed using an instrument called OHIP-EDENT-N10
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?:
False
Is an FDA AA801 Violation?:
None