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

NCT07035574 | Not Yet Recruiting DMC

• 1 other identifier: TUQA2025DENTURE
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edentulism

Keywords

3D Printed Denture Teeth; Wear Analysis; Muscular Efficiency; Digital Dentistry

Outcome Measures

Primary Outcomes (1)

• Amount of Wear

  The amount of wear observed in denture teeth fabricated using conventional techniques versus 3D printing technology. Denture teeth will be scanned at delivery and after 3 months of use, and the wear will be quantified by comparing the scans.

  6 months

Secondary Outcomes (1)

• Muscular Efficiency

  6months

Study Arms (2)

Conventional Denture Teeth

ACTIVE COMPARATOR

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

Other: Conventional Denture Teeth

3D Printed Denture Teeth

EXPERIMENTAL

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

Other: 3D Printed Denture Teeth

Interventions

Conventional Denture Teeth OTHER

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

Conventional Denture Teeth

3D Printed Denture Teeth OTHER

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

3D Printed Denture Teeth

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

tuqa s madhi, B.D.S.

CONTACT

+20 1221905983; salahtuqa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator, Principal Investigator, Prosthodontics Department, Faculty of Dentistry, Cairo University."

Model Details: The study uses a crossover design where participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. This design minimizes individual variability and allows for direct comparison of outcomes.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available 6 months after study completion and will remain accessible for 5 years.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic institutions or research organizations. Researchers must submit a formal request and provide a detailed research proposal outlining the intended use of the data. Data will be shared via secure platforms or repositories, ensuring confidentiality and compliance with ethical guidelines.