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

Patient Satisfaction Clinical Trial

Official title:

Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures. A Randomized Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103019
• Other study ID #: A04080120
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: November 20, 2022

Study information

• Verified date: December 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Fatma mahanna

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	The Oral health-related quality of life (OHRQoL) of the patient was assessed using an instrument called OHIP-EDENT-N A simple score was calculated by adding the responses to all the questions (0 = never; 1= seldom; 2 = fairly often; 3 = often; 4 = very often)	6 months
Secondary	chewing efficiency	two-color mixing ability test (colorimetric method)	6 months