Assessment of Wear and Muscular Efficiency of 3D Printed Versus Conventional Denture Teeth: A Cross-Over In Vivo Study

NCT ID: NCT07035574

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-05-30

Brief Summary

This study aims to evaluate the wear resistance and muscular efficiency of denture teeth fabricated using two different methods: 3D printing and conventional techniques. The research is designed as a crossover in vivo study, where completely edentulous patients will receive both types of dentures sequentially. The primary outcome is the amount of wear observed in the denture teeth over time, while the secondary outcome is the muscular efficiency measured using electromyography (EMG). The study seeks to determine whether 3D printed denture teeth offer advantages in durability and functionality compared to conventionally fabricated denture teeth. Results from this study may provide valuable insights into improving the quality and comfort of dentures for edentulous patients.

Detailed Description

Complete dentures are a common treatment option for edentulous patients, providing essential functionality and aesthetics. With advancements in digital dentistry, 3D printing has emerged as a promising technique for fabricating denture teeth, offering potential benefits such as customization, faster production, and improved material properties. However, the long-term performance of 3D printed denture teeth compared to conventionally fabricated teeth remains under investigation.

This study is designed to assess two critical aspects of denture teeth performance: wear resistance and muscular efficiency. Wear resistance refers to the ability of denture teeth to withstand forces during chewing without significant degradation, while muscular efficiency evaluates how effectively the jaw muscles function with the dentures during activities like chewing and speaking.

The study will recruit completely edentulous patients aged 21-70 years from the Prosthodontics Department at Cairo University. Participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. The crossover design allows for direct comparison within the same group of patients, minimizing individual variability.

Primary impressions will be taken, followed by the fabrication of dentures using standardized protocols. The amount of wear will be measured by scanning the denture teeth at delivery and after three months of use. Muscular efficiency will be assessed using electromyography (EMG) to measure bite force at delivery and after three months.

This study is self-funded and conducted under the supervision of the Prosthodontics Department at Cairo University. Ethical approval has been obtained, and all participants will provide informed consent. The findings of this study are expected to contribute to the advancement of prosthodontic practices, offering evidence-based recommendations for the use of 3D printed denture teeth in clinical settings.

Conditions

Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Denture Teeth

Participants will receive complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth.

Group Type: ACTIVE_COMPARATOR

Conventional Denture Teeth

Intervention Type: OTHER

Complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth.

3D Printed Denture Teeth

Participants will receive complete dentures fabricated using 3D printing technology with custom-designed denture teeth.

Group Type: EXPERIMENTAL

3D Printed Denture Teeth

Intervention Type: OTHER

Complete dentures fabricated using additive manufacturing techniques with advanced resin materials.

Interventions

Conventional Denture Teeth

Complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth.

Intervention Type: OTHER

3D Printed Denture Teeth

Complete dentures fabricated using additive manufacturing techniques with advanced resin materials.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Completely edentulous patients. Aged 21-70 years old. Able to read and sign the informed consent document. Class Ι maxilla-mandibular relationship. Free from temporomandibular disorders. Free from systemic diseases that could affect neuromuscular behaviors or muscular activities.

Edentulous condition falls within Class I and II cases based on the Prosthodontic Diagnostic Index (PDI) classification system for complete edentulism.

Exclusion Criteria

Presence of major medical problems or severe chronic diseases. Poor residual ridge anatomy. Any intra-oral soft or hard tissue abnormalities. Flat, flabby, or knife-edge ridge anatomy.

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• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

tuqa alazawy

Sponsor-Investigator, Principal Investigator, Prosthodontics Department, Faculty of Dentistry, Cairo University."

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

tuqa s madhi, B.D.S.

Role: CONTACT

salahtuqa@yahoo.com

+20 1221905983

Other Identifiers

TUQA2025DENTURE

Identifier Type: -

Identifier Source: org_study_id