Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures.

Sponsor
Fatma mahanna (Other)
Overall Status
Completed
CT.gov ID
NCT06103019
Collaborator
(none)
20
1
2
20.2
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional complete denture
  • Other: 3D complete denture
N/A

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 2.4 plovdiv7290[version 2.4 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A crossover design was conducted. Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed Maxillary and mandibular complete denture.Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months.A crossover design was conducted. Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed Maxillary and mandibular complete denture.Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures. A Randomized Crossover Clinical Trial
Actual Study Start Date :
Mar 15, 2020
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional (complete denture)

Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed complete Maxillary and mandibular complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing denture then the other type of denture was delivered and used for another 3 months.

Other: conventional complete denture
conventional complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

Other: 3D complete denture
3D complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

Active Comparator: 3D printed complete denture

Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed complete Maxillary and mandibular complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing denture then the other type of denture was delivered and used for another 3 months.

Other: conventional complete denture
conventional complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

Other: 3D complete denture
3D complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction [6 months]

    The OHRQoL of the patient was assessed using an instrument called OHIP-EDENT-N

Secondary Outcome Measures

  1. chewing efficiency [6 months]

    two-color mixing ability test (colorimetric method)

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • They were healthy, free from any systemic diseases affecting bone metabolism such as uncontrolled diabetics or osteoporosis. This was achieved through detailed medical history and clinical examination by physician. They had no previous denture experience. Residual alveolar ridges covered with healthy firm mucosa. Angle's class I maxilla-mandibular relationship.
Exclusion Criteria:
  • Systemic disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry, mansoura university Mansoura Dakahlia Egypt 35511

Sponsors and Collaborators

  • Fatma mahanna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma mahanna, lecturer of prosthodontics, Mansoura University
ClinicalTrials.gov Identifier:
NCT06103019
Other Study ID Numbers:
  • A04080120
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Oct 26, 2023