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Completed

NCT Number: NCT06103019

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

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.

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional complete denture

Other

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

Other

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.

Primary outcomes

  1. Patient satisfaction

    Time frame: 6 months

    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)

Secondary outcomes

  1. chewing efficiency

    Time frame: 6 months

    two-color mixing ability test (colorimetric method)

Sponsors and collaborators

Lead sponsor

Fatma mahanna

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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