3D Printing Orientation and Film Thickness for Maxillary Complete Dentures

NCT07740278 | Recruiting

• 1 other identifier: RP-12-24- 2291
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Each participant will receive two maxillary 3D-printed complete dentures fabricated using the same printing orientation (0°, 45°, or 90°) with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. The study will compare the influence of these printing parameters on denture accuracy and patient-reported outcomes to identify the optimal 3D printing settings for complete denture fabrication.

Conditions

Complete Edentulism; Maxillary Complete Denture Rehabilitation; Prosthodontics; 3d Printing; Digital Denture

Keywords

Digital dentistry; Patient satisfaction; Dimensional accuracy; Denture trueness; Layer thickness; Build orientation; CAD/CAM dentures; Additive manufacturing; Three-dimensional printing; Maxillary complete denture; Complete edentulism

Outcome Measures

Primary Outcomes (2)

• Trueness of 3D-printed maxillary complete denture bases

  The trueness of the printed maxillary complete denture bases will be evaluated by comparing the STL file of each scanned denture base with the original CAD design using three-dimensional superimposition analysis.

  immedtiate

• Patient satisfaction

  Patient satisfaction will be assessed using a 10-point Visual Analogue Scale (VAS) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort after wearing each maxillary complete denture.

  3 months

Secondary Outcomes (1)

• Dimensional deviation of 3D-printed maxillary complete denture bases

  3 months

Study Arms (3)

0° Printing Orientation

EXPERIMENTAL

Participants will receive two maxillary complete dentures fabricated using a 0° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction.

Device: 0° 3D-Printed Maxillary Complete Denture

45° Printing Orientation

EXPERIMENTAL

Participants will receive two maxillary complete dentures fabricated using a 45° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction

Device: 45° 3D-Printed Maxillary Complete Denture

90° Printing Orientation

EXPERIMENTAL

Participants will receive two maxillary complete dentures fabricated using a 90° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction.

Device: 90° 3D-Printed Maxillary Complete Denture

Interventions

0° 3D-Printed Maxillary Complete Denture DEVICE

Participants will receive maxillary complete dentures fabricated using a 0° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 0° build orientation on denture trueness, dimensional deviation, and patient satisfaction.

0° Printing Orientation

45° 3D-Printed Maxillary Complete Denture DEVICE

Participants will receive maxillary complete dentures fabricated using a 45° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 45° build orientation on denture trueness, dimensional deviation, and patient satisfaction.

45° Printing Orientation

90° 3D-Printed Maxillary Complete Denture DEVICE

Participants will receive maxillary complete dentures fabricated using a 90° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 90° build orientation on denture trueness, dimensional deviation, and patient satisfaction.

90° Printing Orientation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients with good local and systemic health.
• Patients age ranging from 50 to 70 years old.
• Patients with adequate inter-arch space.
• Patients with good neuromuscular control.

You may not qualify if:

• Patients with any oral diseases which may affect denture construction
• Patients with oral parafunctional habits.
• Patients with tempro-mandibular disorders

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• noha Mamdouh Hamed elkafoury, BDS, MSc

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

noha Mamdouh Hamed elkafoury, BDS, MSc

CONTACT

+201271040849; nohaelkafoury@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Participants will be randomly assigned to one of three 3D printing orientation groups (0°, 45°, or 90°). Within each group, each participant will receive two maxillary complete dentures fabricated using the same printing orientation but with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Each denture will be worn for three months before crossing over to the alternate layer thickness. The crossover design allows within-subject comparison of the effect of layer thickness on trueness, dimensional deviation, and patient satisfaction while minimizing inter-participant variability, whereas comparisons among the three groups will evaluate the influence of printing orientation.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 8, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)